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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT01817322 Completed - Clinical trials for Chronic Renal Disease

Kidney Graft Function Under the Immunosuppression Strategies

MyLowCsA
Start date: June 2011
Phase: Phase 4
Study type: Interventional

To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation without an increase of incidences of adverse events, such as biopsy confirmed acute rejection, local or systemic infections, and bone marrow suppression.

NCT ID: NCT01810939 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

OPAL
Start date: February 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.

NCT ID: NCT01807221 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

ARTS-HF
Start date: June 17, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

NCT ID: NCT01805362 Completed - Clinical trials for Chronic Kidney Disease

RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough

IRAB2
Start date: February 27, 2013
Phase: N/A
Study type: Interventional

Objective: To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough. Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups. Main selection criteria: Inclusion criteria - Chronic kidney disease stage 3 to 4, - ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months, - History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie. Exclusion criteria - Office blood pressure ≥ 160/100 mmHg, - Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor. Evaluation criteria: Primary: Serum aldosterone levels at one year. Secondary: - Serum aldosterone/renin ratio, - 24h urine aldosterone, - Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values, - Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values, - HbA1c, - Urinary albumin/creatinine ratio (UACR) on spot morning urine samples, - Systolic home blood pressure (SBP), - Estimated glomerular filtration rate (eGFR) using the MDRD equation.

NCT ID: NCT01802216 Completed - Clinical trials for Chronic Kidney Disease

Kidney and Periodontal Disease Study

KAPD
Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this study is (1) to determine whether a 12-month trial of patients from underserved communities with clinically significant gum disease and kidney disease randomly assigned to intensive gum disease treatment or delayed treatment is feasible and (2) to determine the variability of various tests of kidney function and inflammation in response to intensive gum disease treatment.

NCT ID: NCT01792661 Completed - Clinical trials for Chronic Kidney Disease

Navigating the Challenges of Chronic Kidney Disease

CKD
Start date: February 2012
Phase: N/A
Study type: Interventional

The study's purpose is to address the challenges of providing stage-appropriate chronic kidney disease (CKD) education and care by developing innovative programs using a CKD Patient Navigator system and an EHR (electronic health record)-based enhanced electronic communication system specific for a CKD patient and her/his physicians/caregivers. The investigators plan a randomized controlled trial of these innovations to examine the utility and effectiveness of these special interventions. The investigators' CKD registry aids in identifying patients for recruitment for the randomized control trial. Patients are randomized into one of four groups. The four groups are: 1) the control group using MyChart; 2) an enhanced personal health record (PHR) included in MyChart consisting of 35 websites chosen to disseminate CKD stage-specific goals of care and CKD education; 3) the patient navigator, a lay professional trained in the specifics of chronic kidney disease navigation with a focus on the needs of their patients based on the National Kidney Foundation Disease Outcomes Quality Initiative; 4) the patient navigator combined with the enhanced MyChart. The investigators hypothesize that a CKD Patient Navigator program will develop a more prepared, proactive patient-caregiver team than usual care; the enhanced PHR will produce a more informed, engaged patient than usual care; the CKD Patient Navigator arm and enhanced PHR will demonstrate a slower rate of decline in eGFR (glomerular filtration rate) than usual care. The results of this study will lay the foundation for a larger multi-center national clinical trial that will build upon the feasibility and knowledge gained from this planning grant.

NCT ID: NCT01788046 Completed - Clinical trials for Hyperparathyroidism, Secondary

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Start date: March 12, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

NCT ID: NCT01786525 Completed - Clinical trials for Chronic Kidney Disease

House Calls and Decision Support: Improving Access to Live Donor Transplantation

Start date: June 2013
Phase: N/A
Study type: Interventional

The main purpose of this research program is to reduce the burden of end-stage organ disease on individuals, families, healthcare systems, and society by increasing the availability of donor organs for transplantation. Consistent with this aim, the project further examines strategies to increase access to and reduce disparities - racial, economic, gender - in live donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of an innovative House Calls intervention developed by the principal investigator by including other minorities and socioeconomically disadvantaged patients and by adding a novel Patient-Centered Decision Support component. The main study hypothesis is that participants receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have a higher proportion of LDKT's by the 2-year study endpoint.

NCT ID: NCT01785875 Completed - Clinical trials for Hyperparathyroidism, Secondary

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

NCT ID: NCT01785849 Completed - Clinical trials for Hyperparathyroidism, Secondary

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Start date: March 12, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.