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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 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…

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…

The effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus in patients with an affective disorder: a pilot study

To study the effect of acetazolamide on lithium-induced NDI.

A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients (CAEB071A2214)

Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…

A Phase 2a, Single-Center Study Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function

The purpose of the trial is to determine the effect of multiple doses of tolvaptan on renal function in patients with autosomal dominant polycystic kidney disease (ADPKD) at various stages of renal function. Additionally, the short-term renal…

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.

Danaparoid dosing during continuous venovenous hemofiltration - a randomized controlled pilot study investigating two danaparoid dosing schemes with a standard heparin dosing scheme

The aims of the current study are1. to investigate the efficacy and safety of a continuous infusion of 'low dose' danaparoid in patients with acute renal failure needing CRRT2. to investigate whether repeated measurements of anti-Xa levels…

A Phase I Study of Oral Topotecan in Subjects with Cancer and
Impaired Renal Function

Primary• To determine the safety profile of oral topotecan in subjects with cancer andmildly moderately or severely impaired renal function (Groups C, D and E) compared to subjects with cancerwhose renal function is normal and who have received…

Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery

To assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass.To assess the anti-inflammatory effects of EA-230 in patients with systemic inflammation following cardiac surgery. To assess the effects…

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy

The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.The secondary objectives of this study include evaluation of:1. The safety of avacopan…

A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1.

Primary:* Evaluate the long-term safety of multiple doses of ALN-GO1 in patients with PH1.Secundary:* Evaluate the pharmacodynamic (PD) effect of ALN-GO1 on urinary oxalate excretion* Characterize the effect of ALN-GO1 on markers of renal function.…

Rescue Alkaline Phosphatase In Defense against all cause Acute Kidney Injury

To study the potential renoprotective effects of supplementation of alkaline phosphatase in hospitalized patients with AKI

An open-label, multi-center, roll-over study to assess long term safety of lenvatinib monotherapy or lenvatinib combination regimen or comparator treatment arm to cancer patients in Eisai sponsored lenvatinib trials

The primary objective is to assess long-term safety of study drug(s) in subjects who are enrolled in Eisai-sponsored lenvatinib studies.

A Phase 2b Multicentre, Randomised, Double-Blind, Active Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin
in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2

· To evaluate the effect of zibotentan anddapagliflozin in combination and alone versusplacebo on UACR.

Alkaline Phosphatase as treatment of Ischemia Reperfusion Injury to prevent delayed graft function in deceased donor kidney transplantation

This study has been transitioned to CTIS with ID 2024-515480-66-01 check the CTIS register for the current data. To attenuate the impact and duration of delayed graft funtion by dampening schemia reperfusion injury

A GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease

This study has been transitioned to CTIS with ID 2023-506637-30-00 check the CTIS register for the current data. The main objective of this study is to determine whether lowering estrogen and progesterone levels with leuprorelin decreases liver…

Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma

This study has been transitioned to CTIS with ID 2022-502123-21-00 check the CTIS register for the current data. To compare the 120 mg once daily (QD) dose and 200 mg QD dose of MK*6482with respect to objective response rate (ORR) based on Response…

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03A

This study has been transitioned to CTIS with ID 2023-506838-68-00 check the CTIS register for the current data. Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment…