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A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…

Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI).;Open randomized 12 month study.

The goal of this study is to prove whether kidney transplant recipients can reduce their risk of cardiovascular disease bij converting to Nulojix.

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.

Neurotoxic adverse effects of morphine and oxycodone in continuous subcutaneous infusion for treatment of pain in terminal patients with diminished renal function: a Randomized Controlled Trial.

The primary objective of this study is to compare the prevalence of delirium between oxycodone and morphine, administered by CSCI, for the treatment of pain in dying patients with a diminished renal function.The secondary objective is to compare the…

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…

Treatment of severe hypertension in end-stage renal failure: Effect of renal denervation in dialysis patients and patients with renal transplant.

The purpose of this study is to demonstrate the effectiveness of renal denervation in lowering blood pressure in patients with therapy-resistant hypertension and end-stage renal disease who are on dialysis or who have a renal transplant.

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 single arm Pharmacokinetic/Pharmacodynamic Study of Sunitinib and Pazopanib in Patients with Metastasized Renal Cell Carcinoma

The primary goal of this research is to develop a pharmacokinetic/pharmacodynamic (PK/PD) model for sunitinib and pazopanib in patients with metastatic renal cell carcinoma, so that the possible use of biomarkers can be tested as predictors for the…

A phase IV, blinded, randomized controlled trial to compare the effectiveness of low pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize the quality-of-recovery during the early post-operative phase

To investigate whether the use of low pressure pneumoperitoneum during laparoscopic donor nephrectomy improves the quality-of-recovery during the early post-operative phase as compared to the use of standard pressure pneumoperitoneum.

A randomized controlled trial comparing deep versus moderate neuromuscular block - in low pressure pneumoperitoneum - to optimize the surgical conditions during laparoscopic donor nephrectomy

To investigate whether the use of deep neuromuscular block improves surgical conditions in low pressure laparoscopic donor nephrectomy

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…

Optical biopsy to improve the diagnosis of kidney cancer: a prospective, observational, multicentre, in-vivo study.

To evaluate the accuracy and adverse events of combined use of minimal invasive optical coherence tomography (OCT) to differentiate normal tissue from (different types of) malignant tissue in kidneys.

Pharmacokinetics of ertapenem in a three-weekly dosing regime in patients with end stage renal disease depending on hemodialysis

To investigate the Ertapenem plasmaconcentration time curves in a dosingscheme of three administrations per week after hemodialysis in patients with end stage renal disease depending on hemodialysis. To find a pharmacokinetic model to describe…

A prospective, open, randomized, single center study comparing the effects of duo therapy with Everolimus and steroids versus triple treatment of low dose calcineurin inhibitor, low-dose MMF and steroids at least one year after renal transplantation.
Effects on renal function, tolerability, chronic allograft damage, cardiovascular parameters and malignancies.

Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…

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…

Autologous BM derived MSCs in combination with everolimus to preserve renal structure and function in renal recipients

A 6-month study of efficacy and safety comparing concentration-controlled Certican® with MSCs to Certican® with standard tacrolimus in renal transplant recipients

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.

PHASE II STUDY OF LUTETIUM-177 LABELED CHIMERIC MONOCLONAL ANTIBODY cG250 (177Lu-DOTA-cG250) IN PATIENTS WITH ADVANCED RENAL CANCER

Primary objective:- To determine the clinical efficacy of multiple doses of 177Lu-DOTA-cG250 at MTD in patients with advanced renal cancer using RECIST criteriaSecondary objectives:- To determine the toxicity of the treatment as defined by NCI…