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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT02302287 Active, not recruiting - Clinical trials for Chronic Renal Insufficiency

Renal Effects of Meditarranean Diet and Low-protein Diet With Ketoacids on Physiological Intestinal Mibrobiota in CKD

MEDIKA
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Food intake has a deep influence on gut microbiota composition and function, both in health and in disease status. In chronic kidney disease (CKD), a microbiota dysbiosis status is observed. Moreover, many toxic uremic molecules are microbial-derived and their accumulation promotes, in turn, disease progression. Investigators' hypothesis foresees a beneficial effect of nutritional treatments, able to restore gut microbiota balance, to lower microbial-derived uremic toxins and to improve clinical conditions in CKD patients. Mediterranean Diet (MD) is supposed to have beneficial effect on microbiota composition, while low-protein diet supplemented with ketoacids (KD) is used in CKD patients for the improvement of clinical conditions, but its effects on gut microbiota are currently unknown. Investigators' project aim is to verify the effects of MD and KD on: microbiota and metabolome composition, microbial-derived uremic toxins level and clinical conditions in a cohort of CKD patients.

NCT ID: NCT02301026 Completed - Clinical trials for Anaemia in Chronic Kidney Disease

A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency

DINO
Start date: September 1, 2014
Phase: N/A
Study type: Observational

The purpose of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in haemodialysis patients with Chronic Kidney Disease.

NCT ID: NCT02299661 Completed - Clinical trials for Chronic Renal Disease

Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney Disease

Start date: November 2014
Phase: Phase 1
Study type: Interventional

DS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to produce transient dose / exposure dependent increases in erythropoietin levels in subjects with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to dose will be randomised. On completion of this part of the study an optional fourth dose may be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects (n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from Part A.

NCT ID: NCT02299310 Not yet recruiting - Clinical trials for Chronic Kidney Disease

Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease

Start date: November 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.

NCT ID: NCT02294643 Completed - Clinical trials for Coronary Artery Disease

Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' Study

SERENADE
Start date: April 2009
Phase: Phase 3
Study type: Interventional

The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in patients with CKD or DM after DES implantation.

NCT ID: NCT02289703 Completed - Clinical trials for End-Stage Renal Disease

A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy participants with a creatinine clearance (CLcr) greater than equal to (>=) 80 milliliter per minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on maintenance hemodialysis (a method used to remove waste material from the blood when the kidneys are unable to do so).

NCT ID: NCT02286258 Terminated - Kidney Diseases Clinical Trials

Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)

MultiGFR
Start date: October 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.

NCT ID: NCT02282813 Completed - Clinical trials for Chronic Kidney Disease

Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

Start date: April 2013
Phase: Phase 3
Study type: Interventional

This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in stage 3 or 4 chronic kidney disease patients.

NCT ID: NCT02281045 Completed - Clinical trials for Chronic Kidney Disease

CITrate and Evodial for Effective Dialysis (CITED) Study

CITED
Start date: October 2014
Phase: N/A
Study type: Interventional

It is not known whether the combination of a heparin-grafted membrane plus citrate-containing dialysate is a valid alternative to regional citrate anticoagulation. This is a cross-over non-inferiority trial comparing these two anticoagulation strategies

NCT ID: NCT02276742 Completed - Obesity Clinical Trials

Lifestyle Management of CKD in Obese Diabetic Patients

Start date: October 2014
Phase: N/A
Study type: Interventional

The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.