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Levosimendan in Acute Kidney Injury Study

The objective of this study is to investigate whether Levosimendan is able to lower creatinine levels as a measure of kidney failure and if urinary output can be increased.

A randomized double-blind placebo-controlled study to evaluate the
efficacy and safety of Cinryze® (C1 esterase inhibitor [human]) for the
treatment of acute antibody-mediated rejection in kidney transplant
patients

To evaluate the efficacy of Cinryze administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free intravenous immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft…

The LIPMAT study: Liposomal prednisolone to improve hemodialysis fistula maturation

To demonstrate whether liposomal prednisolone is effective in promoting AVF maturation after surgical creation of a radiocephalic AVF.

A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.

Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…

A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of BAY 94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart failure with left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone versus eplerenone

Primary objective of the study is• To investigate efficacy and safety of different oraldoses of BAY94-8862 given once daily over 90 daysThe secondary objectives are:•To assess the effects of these doses on a compositeendpoint of death from any cause…

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background Cyclophosphamide or Rituximab Treatment

This study is set-up to evaluate the safety and tolerability of CCX168 in subjects with mild to moderate AARV on a background of cyclophosphamide treatment. It will assess the possibility to optimize the treatment with CCX168 and to reduce the side…

Randomized double blind placebo-controlled clinical safety, tolerability and pharmacokinetic/-dynamic study on the effects of escalating single intravenous doses of EA-230 on the innate immune response during experimental human endotoxemia

Part 1: To assess the safety, tolerability and pharmacokinetic-dynamic response, of single escalating doses of EA-230 in healthy subjects.Part 2: To assess the dose-and plasma concentration-response relation of single escalating doses EA-230 on…

A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the
Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C
Virus Infection and Chronic Kidney Disease

Advances in the treatment of patients with hepatitis C infection have contributed to improved efficacy in several populations. However, for patients with CKD, particularly those with stages 3-5, treatment options remain limited and suboptimal. Given…

Urological complications after live donor kidney transplantation: intravesical or extravesical ureterovesical anastomosis?

Main objective: Does the use of the extravesical ureterovesicostomy reduce the incidence of PCN placement, and urological complications?Secondary objective: Does the use of the extravesical ureterovesicostomy reduces the rate of re-operations and re…

A STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF LY3045697 AFTER SINGLE ORAL DOSING IN HEALTHY SUBJECTS

Primary : To evaluate the safety and tolerability of single oral doses of LY3045697 administered to healthy subjects Secondary : To investigate the pharmacokinetics of single oral doses of LY3045697 administered to healthy subjects Exploratory : To…

A STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF LY3045697 AFTER MULTIPLE ORAL DOSING IN HEALTHY SUBJECTS

Primary: To evaluate the safety and tolerability of LY3045697 after multiple oral dosing in healthy subjectsSecondary: To investigate the pharmacokinetics of LY3045697 after multiple oral dosing in healthy subjects

A Single-Centre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARA 290 Administered Intravenously to End-Stage Renal Disease Patients

The present study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARA 290 administered intravenously to patients with ESRD.

A Phase I, Single-Centre, Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARA 290 Administered Intravenously to Healthy Subjects, and extension in renal patients

The present study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARA 290 administered intravenously to healthy subjects, and of intravenously and subcutaneously administered ARA 290 to renally impaired subjects.

Protocol CKI-302 KW-3902IV in the treatment of subjects with acute heart failure syndrome
A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy

To evaluate the effect of KW-3902IV in addition to IV loop diuretic therapy on heart failure signs and symptoms, persistent renal dysfunction, morbidity and mortality, and safety in subjects hospitalized with acute heart failure syndrome, volume…

Protocol CKI-301 KW-3902IV in the treatment of subjects with acute heart failure syndrome
A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy

To evaluate the effect of KW-3902IV in addition to IV loop diuretic therapy on heart failure signs and symptoms, persistent renal dysfunction, morbidity and mortality, and safety in subjects hospitalized with acute heart failure syndrome, volume…

Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients

Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?

A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease

Primary objective:* Evaluate long-term effect of tolvaptan in ADPKD through rate of renal volume change(%) for tolvaptan-treated compared to placebo-treated subjects.Secondary objectives:* Evaluate long-term efficacy of tolvaptan in ADPKD through a…

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, International Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary Hyperoxaluria.

Primary Objective:To evaluate the efficacy of Oxabact TM to reduce urinary oxalate levels from Baseline to Week 24 in subjects with Primary Hyperoxaluria (PH).Secondary Objectives:To evaluate:* Percentage of subjects who have 20% or greater…

A Phase 2/3, double-blind, randomized, placebo-controlled, multi-center study to evaluate the efficacy and safety of OxabactTM to reduce urinary oxalate in subjects with Primary Hyperoxaluria.

Primary Objective:To evaluate the efficacy of OxabactTM to reduce urinary oxalate levels (molar oxalate to creatinine ratio) from Baseline to Week 24 in subjects with Primary Hyperoxaluria (PH).Secondary Objectives- To evaluate the safety of…

Anti-inflammatory effects of rosiglitazone in patients with stage 4 and 5 chronic kidney disease

The primary aim of this study will be to determine the effect of rosiglitazone on intima media thickness and calcification in patients with stage 4 and 5 CKD. The secondary end points are the effects on pulse wave velocity, blood pressure, the lipid…