Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05056727
Other study ID # D9488C00001
Secondary ID 2021-001911-96
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 30, 2021
Est. completion date February 7, 2024

Study information

Verified date March 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate [eGFR] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.


Description:

This is a Phase 3, international, randomised withdrawal, double-blind, parallel-group, placebo-controlled study, to evaluate the effect of SZC as adjunct to RAASi therapy (lisinopril or valsartan) in slowing CKD progression in participants with CKD and hyperkalaemia or at risk of hyperkalaemia. Specifically, the study will include participants with hyperkalaemia (S-K > 5.0 to ≤ 6.5 mmol/L by central laboratory) who are on adequate or limited RAASi therapy due to hyperkalaemia, and participants with normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L by central laboratory) who are on limited RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as (1) participants with a previous medical history or record of hyperkalaemia within the prior 24 months who are on limited RAASi therapy despite indication in CKD; (2) participants in whom RAASi therapy is indicated in CKD but are on limited RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L; and (3) participants in whom RAASi therapy has been discontinued or reduced to suboptimal doses because of hyperkalaemia. A participant is expected to be in the study for approximately 28 months, which includes up to 13 days for the screening period, 27 months for the intervention period, and 1 week for follow-up. The 27-month intervention period of the study consists of 3 phases, an initiation phase (up to 72 hours), a run-in phase (3 months/up to Day 90), and a maintenance phase (24 months/104 weeks). The initial dose of SZC will be administered to participants during the initiation phase. No changes will be made to the ACEi or ARB therapy at this stage. As soon as possible after the participant is confirmed to be normokalaemic at the end of the initiation phase, the participant will enter the run-in phase. Participants will receive open-label SZC and either lisinopril or valsartan. The aim of the run-in phase is to increase ACEi or ARB therapy stepwise to their maximum doses. After a 3-month run-in period for RAASi dose optimization while on SZC, participants will be randomized to SZC or placebo and followed during the subsequent 24 months of maintenance phase for efficacy and safety assessments.


Recruitment information / eligibility

Status Terminated
Enrollment 716
Est. completion date February 7, 2024
Est. primary completion date February 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria: - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol - Must be = 18 years of age at the time of signing the informed consent. - Must have eGFR = 25 and = 59 mL/min/1.73m2 as calculated by central laboratory (CKD-EPI formula) at screening (Visit 1) - Must have UACR = 200 and = 5000 mg/g as calculated by central laboratory at screening (Visit 1). If the first sample does not fulfil eligibility criteria, a second sample can be obtained during the screening period; if so, the UACR measurement from the second sample must be within the eligibility range. - Any of the following criteria, a or b, at screening (Visit 1): 1. Cohort A: Hyperkalaemia (S-K > 5.0 to = 6.5 mmol/L) as measured by the central laboratory, and on adequate* or limited** RAASi therapy due to hyperkalaemia. 2. Cohort B: Normokalaemia (S-K = 3.5 to = 5.0 mmol/L) as measured by the central laboratory and on limited** RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as: (i) Participants with a previous medical history or record of hyperkalaemia within the prior 24 months, who are on limited** RAASi therapy despite indication in CKD. (ii) Participants in whom RAASi therapy is indicated in CKD, who are on limited** RAASi therapy and have S-K = 4.7 to = 5.0 mmol/L. (iii) Participants in whom RAASi therapy has been discontinued or reduced to suboptimal* doses because of hyperkalaemia. *Adequate RAASi dose levels are defined in protocol; doses lower than these are considered as suboptimal. **Limited RAASi therapy is defined as no or suboptimal RAASi therapy according to dosing guidance provided in protocol. - If on thiazide or loop diuretics, the dose must have been stable for 2 weeks prior to screening (Visit 1). - If on RAASi therapy, the dose must have been stable for one month prior to screening (Visit 1) and remain stable during screening. - If on an SGLT2i treatment (ie, dapagliflozin and canagliflozin), finerenone, or any other medications in these 2 classes that are approved for CKD, the dose must have been stable for 3 months prior to screening (Visit 1). - Participants must be one-year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of one month prior to screening (Visit 1) and willing to remain on the birth control until one month after the last dose of study intervention. Exclusion Criteria: - New York Heart Association class III to IV congestive heart failure at the time of screening (Visit 1) or previous history of severe or symptomatic heart failure. - Myocardial infarction, unstable angina, stroke, or transient ischaemic attack within 3 months prior to screening (Visit 1). - Participants with a known history of systolic blood pressure = 160 mmHg or diastolic blood pressure = 95 mmHg within 2 weeks prior to screening (Visit 1) are excluded. In addition, any participant with systolic blood pressure = 160 mmHg or diastolic blood pressure = 95 mmHg as measured at screening (Visit 1) and confirmed by repeated measurement is excluded. Participants may be rescreened once blood pressure is controlled. - QTcF > 550 msec at screening (Visit 1). - History of QT prolongation associated with other medications that required discontinuation of that medication. - Congenital long QT syndrome. - Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation and heart rate controlled by medication are permitted. - Lupus nephritis or anti-neutrophil cytoplasmic antibody-associated vasculitis. - Change in renal function requiring hospitalisation or dialysis within 3 months prior to screening (Visit 1). - History of renal transplant (or anticipated need for renal transplant during the study). - Severe hepatic impairment, biliary cirrhosis, or cholestasis. - History of hereditary or idiopathic angioedema. - Any prior hypersensitivity to ACEi or ARB that in the investigator's judgment precludes use of lisinopril and valsartan/irbesartan. Prior hypersensitivity reactions to consider include, but are not limited to, development of angioedema, icterus, hepatitis, or neutropaenia or thrombocytopaenia requiring treatment modification. - Known hypersensitivity or previous anaphylaxis to SZC or to components thereof. - Any condition outside the CV and renal disease area such as, but not limited to, malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgment. - Active malignancy requiring treatment at the time of screening (Visit 1), except for successfully treated basal cell or treated squamous cell carcinoma. - S-K > 6.5 or < 3.5 mmol/L by local laboratory within 1 day prior to the scheduled first dose of SZC in the initiation phase. - Evidence of COVID-19 infection within 2 weeks prior to screening (Visit 1). - Treated with dual blockade of RAAS (combined use of an ACEi and ARB) within 3 months prior to screening (Visit 1). - Treated with an angiotensin receptor neprilysin inhibitor (ARNI; sacubitril/valsartan [Entresto®]) within 3 months prior to screening (Visit 1). - Treated with an MRA not approved for CKD within 3 months prior to screening (Visit 1). - Treated with aliskiren-containing products with 3 months prior to screening (Visit 1). - Treated with SPS (eg, Kayexalate, Resonium), CPS (Resonium Calcium), patiromer (Veltassa®), or SZC (Lokelma®) within 7 days prior to screening (Visit 1). - Participation in another clinical study with an investigational product administered within one month prior to screening (Visit 1). - Not willing or not able to change to lisinopril or valsartan/irbesartan, the protocol-mandated RAASi study intervention. Note: For participants taking a fixed combination of an ACEi or ARB with another agent (eg, calcium blockers or diuretics) as SoC, the investigator must make a judgment that it will be safe and efficacious for such participants to change to the study ACEi or ARB and to the other drug as separate agents. - Previous dosing with SZC in the present study. - Currently pregnant (confirmed with positive pregnancy test at screening [Visit 1]) or breastfeeding. - Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements. - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

Study Design


Intervention

Drug:
Sodium Zirconium Cyclosilicate (SZC)
Powder for oral suspension in a sachet. Unit dose strength: 5 or 10 g SZC. Single dose will consist of 1-3 sachets. During Initiation Phase: S-K > 5 to = 6.5 mmol/L (measured by L-Lab): Single dose contains 10 g SZC that should be suspended in 45 mL of water. The 10 g SZC single dose should be administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L); the total daily dose is 30 g SZC. S-K = 3.5 to = 5 mmol/L (measured by L-Lab): Single dose contains 5 g SZC that should be suspended in 45 mL of water and administered once daily for 48 hours. During Run-in and Maintenance Phases: - Single dose contains 5 g SZC administered every other day or 5, 10, or 15 g SZC administered once daily that should be suspended in 45 mL of water.
Placebo
Powder for oral suspension in a sachet. Placebo to match 5 or 10 g. Single dose will consist of 1-3 sachets. During Maintenance Phase: - Single dose contains 5 g placebo administered every other day or 5, 10, or 15 g placebo administered once daily that should be suspended in 45 mL of water.
Lisinopril
Tablet for oral administration. Unit dose strength: 2.5, 5, 10 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily.
Valsartan
Tablet or capsule for oral administration. Unit dose strength: 40, 80 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily.
Irbesartan
Tablet for oral administration. Unit dose strength: 75, 150 or 300 mg. Dosage level: 75, 150, or 300 mg administered once daily. The study is designed to use valsartan as the selected ARB therapy adjunct to SZC. However, if an actual shortage of valsartan in a local market jeopardises the ability of participants to enter or continue in the study, valsartan can be temporarily substituted with irbesartan until the shortage of valsartan is resolved.

Locations

Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Buenos Aires
Argentina Research Site Caba
Argentina Research Site La Plata
Argentina Research Site Mar del Plata
Argentina Research Site Mar del Plata
Argentina Research Site Rosario
Argentina Research Site San Vicente
Argentina Research Site Sarandi
Brazil Research Site Curitiba
Brazil Research Site Fortaleza
Brazil Research Site Joinville
Brazil Research Site Maringá
Brazil Research Site Porto Alegre
Brazil Research Site Porto Alegre
Brazil Research Site Sao Paulo
Brazil Research Site Sao Paulo
Bulgaria Research Site Blagoevgrad
Bulgaria Research Site Botevgrad
Bulgaria Research Site Dupnitsa
Bulgaria Research Site Gorna Oryahovitsa
Bulgaria Research Site Gotse Delchev
Bulgaria Research Site Kozloduy
Bulgaria Research Site Lom
Bulgaria Research Site Pleven
Bulgaria Research Site Plovdiv
Bulgaria Research Site Plovdiv
Bulgaria Research Site Plovdiv
Bulgaria Research Site Samokov
Bulgaria Research Site Sandanski
Bulgaria Research Site Silistra
Bulgaria Research Site Sliven
Bulgaria Research Site Smolyan
Bulgaria Research Site Stara Zagora
Bulgaria Research Site Yambol
Canada Research Site Montreal Quebec
Canada Research Site Montreal Quebec
Canada Research Site Oshawa Ontario
Canada Research Site Saint John New Brunswick
China Research Site Baotou
China Research Site Beijing
China Research Site Beijing
China Research Site Beijing
China Research Site Beijing
China Research Site Beijing
China Research Site Beijing
China Research Site Changchun
China Research Site Changsha
China Research Site Chengdu
China Research Site Chengdu
China Research Site Chongqing
China Research Site Guangzhou
China Research Site Guangzhou
China Research Site Guangzhou
China Research Site Guangzhou
China Research Site Guiyang
China Research Site Hangzhou
China Research Site Hefei
China Research Site Hengyang
China Research Site Huizhou
China Research Site Lanzhou
China Research Site Nanchang
China Research Site Nanjing
China Research Site Nanjing
China Research Site Nanjing
China Research Site Ningbo
China Research Site Sanya
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shantou
China Research Site Shengyang
China Research Site Shenyang
China Research Site Shenzhen
China Research Site Taiyuan
China Research Site Urumqi
China Research Site Wuhan
China Research Site Wuhan
China Research Site Wuxi
China Research Site Xi'an
China Research Site Xuzhou
China Research Site Yantai
China Research Site Yinchuan
China Research Site Zhengzhou
China Research Site Zhuzhou
India Research Site Coimbatore
India Research Site Kolkata
India Research Site Madurai
India Research Site New Delhi
Italy Research Site Bari
Italy Research Site Bassano del Grappa
Italy Research Site Bologna
Italy Research Site Brescia
Italy Research Site Messina
Italy Research Site Pavia
Italy Research Site Roma
Italy Research Site Roma
Italy Research Site Rozzano
Italy Research Site San Giovanni Rotondo
Italy Research Site Verona
Japan Research Site Amagasaki-shi
Japan Research Site Atsugi-shi
Japan Research Site Chiba-shi
Japan Research Site Chuo-ku
Japan Research Site Chuo-ku
Japan Research Site Chuo-shi
Japan Research Site Fukuoka-shi
Japan Research Site Kamakura-shi
Japan Research Site Kanoya-shi
Japan Research Site Kasugai-shi
Japan Research Site Kawachinagano-shi
Japan Research Site Kawasaki-shi
Japan Research Site Kitakyushu
Japan Research Site Kitakyushu-shi
Japan Research Site Koriyama-shi
Japan Research Site Koshigaya-shi
Japan Research Site Kumamoto-shi
Japan Research Site Kure-shi
Japan Research Site Marugame-shi
Japan Research Site Matsumoto-shi
Japan Research Site Matsusaka-shi
Japan Research Site Matsuyama-shi
Japan Research Site Nagoya-shi
Japan Research Site Nagoya-shi
Japan Research Site Naka-shi
Japan Research Site Noda-shi
Japan Research Site Oita-shi
Japan Research Site Omihachiman-shi
Japan Research Site Osaka-city
Japan Research Site Osaka-shi
Japan Research Site Sakai-shi
Japan Research Site Takarazuka-shi
Japan Research Site Toyota City
Japan Research Site Toyota-Shi
Japan Research Site Tsu-shi
Japan Research Site Tsuchiura-shi
Japan Research Site Urayasu-shi
Japan Research Site Yaizu-shi
Japan Research Site Yokohama-shi
Japan Research Site Yokohama-shi
Japan Research Site Yokohama-shi
Japan Research Site Yonago-shi
Malaysia Research Site Alor Setar
Malaysia Research Site Batu Caves
Malaysia Research Site Johor Bahru
Malaysia Research Site Kajang
Malaysia Research Site Kuala Lumpur
Malaysia Research Site Kuala Lumpur
Malaysia Research Site Kuala Lumpur
Malaysia Research Site Seri Manjung
Mexico Research Site Cuauhtemoc
Mexico Research Site Culiacán
Mexico Research Site Guadalajara
Mexico Research Site Mazatlán
Mexico Research Site Merida
Mexico Research Site Merida
Mexico Research Site Mexico
Mexico Research Site Mexico
Mexico Research Site San Luis Potosí
Mexico Research Site Veracruz
Philippines Research Site Davao City
Philippines Research Site Iloilo City
Poland Research Site Kraków
Poland Research Site Lódz
Poland Research Site Poznan
Poland Research Site Rzeszow
Poland Research Site Tczew
Puerto Rico Research Site Ponce
Russian Federation Research Site Aramil
Russian Federation Research Site Moscow
Russian Federation Research Site Perm
Russian Federation Research Site Rostov-on-Don
Russian Federation Research Site Saint Petersburg
Spain Research Site Almeria
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site Getafe
Spain Research Site L'Hospitalet de Llobregat
Spain Research Site Lugo
Spain Research Site Madrid
Spain Research Site Sevilla
Spain Research Site Tenerife
Spain Research Site Valencia
Spain Research Site Valencia
Taiwan Research Site Hualien City
Taiwan Research Site Kaohsiung
Taiwan Research Site Kaohsiung
Taiwan Research Site Kaohsiung
Taiwan Research Site Keelung
Taiwan Research Site New Taipei
Taiwan Research Site New-Taipei
Taiwan Research Site Taichung
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Tainan City
Taiwan Research Site Taipei
Taiwan Research Site Taipei City
Taiwan Research Site Taipei City
Taiwan Research Site Taoyuan
Thailand Research Site Bangkok
Thailand Research Site Bangkok
Thailand Research Site Chaingmai
Thailand Research Site Hat Yai
Thailand Research Site Ratchathewi
Turkey Research Site Adapazari
Turkey Research Site Ankara
Turkey Research Site Ankara
Turkey Research Site Ankara
Turkey Research Site Antalya
Turkey Research Site Gaziantep
Turkey Research Site Istanbul
Turkey Research Site Izmir
Turkey Research Site Kahramanmaras
Turkey Research Site Kayseri
Turkey Research Site Kocaeli
Ukraine Research Site Dnipropetrovsk
Ukraine Research Site Kharkiv
Ukraine Research Site Kyiv
Ukraine Research Site Kyiv
Ukraine Research Site Kyiv
Ukraine Research Site Kyiv
Ukraine Research Site Lutsk
Ukraine Research Site Vinnytsya
Ukraine Research Site Zaporizhzhia
Ukraine Research Site Zhytomyr
United States Research Site Albany New York
United States Research Site Albuquerque New Mexico
United States Research Site Arlington Texas
United States Research Site Bethlehem Pennsylvania
United States Research Site Boston Massachusetts
United States Research Site Boston Massachusetts
United States Research Site Boynton Beach Florida
United States Research Site Canyon Country California
United States Research Site Chattanooga Tennessee
United States Research Site Chester Pennsylvania
United States Research Site Chicago Illinois
United States Research Site Chula Vista California
United States Research Site Cincinnati Ohio
United States Research Site Columbia South Carolina
United States Research Site Columbia Missouri
United States Research Site Denver Colorado
United States Research Site Flint Michigan
United States Research Site Fort Wayne Indiana
United States Research Site Fort Worth Texas
United States Research Site Great Neck New York
United States Research Site Hialeah Florida
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Houston Texas
United States Research Site Kansas City Missouri
United States Research Site Lauderdale Lakes Florida
United States Research Site Louisville Kentucky
United States Research Site Nampa Idaho
United States Research Site Newport News Virginia
United States Research Site Northridge California
United States Research Site Oak Brook Illinois
United States Research Site Ocoee Florida
United States Research Site Orangeburg South Carolina
United States Research Site S. Gate California
United States Research Site Saint Clair Shores Michigan
United States Research Site San Antonio Texas
United States Research Site San Dimas California
United States Research Site Surprise Arizona
United States Research Site Tarzana California
United States Research Site Temple Terrace Florida
United States Research Site Tucson Arizona
United States Research Site Winston-Salem North Carolina
Vietnam Research Site Bien Hoa
Vietnam Research Site Da Nang
Vietnam Research Site Hanoi
Vietnam Research Site Ho Chi Minh
Vietnam Research Site Ho Chi Minh
Vietnam Research Site Ho Chi Minh City
Vietnam Research Site Hue

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Brazil,  Bulgaria,  Canada,  China,  India,  Italy,  Japan,  Malaysia,  Mexico,  Philippines,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Other AEs/SAEs During screening only SAEs will be collected.
Assessments related to AEs cover:
Occurrence/frequency
Relationship to study intervention as assessed by investigator
Intensity
Seriousness
Death
AEs leading to discontinuation of study intervention
From screening visit to follow-up visit at Week 105
Primary Co-primary: Total eGFR slope and Chronic eGFR slope Both of the primary endpoints must be met in order for the study to be declared successful, i.e., co-primary endpoints Co-primary: Total slope: from randomisation visit to the end of the maintenance phase at Week 104; Chronic slope: from Week 12 visit to the end of the maintenance phase at Week 104
Secondary Time from randomisation to the first occurrence of any component in the composite of: Sustained = 40% decline in eGFR; Onset of ESKD (kidney transplantation, maintenance dialysis, or sustained low eGFR); Death from kidney failure From randomisation visit to the end of the maintenance phase at Week 104
Secondary Time from randomisation to first lisinopril/valsartan dose decrease From randomisation visit to the end of the maintenance phase at Week 104
Secondary UACR measurements From randomisation visit to the end of the maintenance phase at Week 104
Secondary Serum bicarbonate measurements From randomisation visit to the end of the maintenance phase at Week 104
Secondary S-K level classification Normal (3.5-5.0 mmol/L) or non-normal (< 3.5 or > 5.0 mmol/L) From randomisation visit to the end of the maintenance phase at Week 104
See also
  Status Clinical Trial Phase
Withdrawn NCT01655186 - A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus Phase 2
Completed NCT03481686 - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections N/A
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Enrolling by invitation NCT02237534 - Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia Phase 4
Completed NCT02126293 - Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant Phase 3
Terminated NCT01533545 - Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients N/A
Completed NCT03280615 - Omega 3 Fatty Acids in Patients With Chronic Renal Disease Phase 3
Completed NCT04498156 - Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)
Recruiting NCT04020328 - Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency Phase 4
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed NCT03836508 - Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis N/A
Completed NCT03250715 - Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure N/A
Completed NCT03577249 - Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation Phase 2/Phase 3
Completed NCT01975818 - Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 Phase 2
Active, not recruiting NCT05766644 - App-based Education Program for CKD N/A
Active, not recruiting NCT02791880 - Acute Kidney Injury Genomics and Biomarkers in TAVR Study
Recruiting NCT02947750 - Neurovascular Transduction During Exercise in Chronic Kidney Disease Phase 2
Terminated NCT02286258 - Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR) Phase 1/Phase 2
Completed NCT01711853 - Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease. Phase 1
Completed NCT00509262 - Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1) Phase 3