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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 Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment

The primary objective of this study is:- To evaluate the effect of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) on renal parameters at Week 24The secondary objectives of this study are:- To…

SYMPATHY: Renal sympathetic denervation as a new treatment for therapy resistant hypertension.

The primary objective is to assess whether RD added to usual care compared to usual care alone reduces BP (24-h or average day-time SBP as determined with the use of ambulatory BP monitoring (ABPM)) in subjects with an average mean day-time SBP of…

A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Primary Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysisSecondary Objective: To characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (…

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…

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

The primary objective of this study is to evaluate the efficacy of roxadustat compared todarbepoetin alfa in the treatment of anemia in non-dialysis dependent Chronic Kidney Disease (NDD-CKD)subjects.The secondary objectives of this study are to:*…

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…

Vitamin K1 to slow vascular calcification in hemodialysis patients (VitaVasK)

The aim of the study is to show that a therapy based on a thrice weekly administration (i.e. at each HD session) of vitamin K1 for a period of 18 months attenuates the progression of coronary artery and thoracic aortic calcifications compared to…

A Multicenter single-arm Extension Study to Describe the Long-term Safety
of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With
Chronic Kidney Disease on Hemodialysis.

Primary: characterize the long-term safety and tolerability of AMG 416 in the treatment of secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis.Secondary: to characterize intact parathyroid hormone (iPTH…

Effect of N-acetylcysteine on hydrogen sulfide in chronic kidney disease

Primary Objective: Our primary objective is to investigate the effect of NAC on H2S levels in plasma in different patient groups, i.e. healthy volunteers, CKD patients, and dialysis patients. We hypothesize that there is an increase in H2S levels…

Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentrationcontrolled
everolimus in liver transplant recipients.

To evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.

A Randomized, Open-Label, Phase 3 Study to Compare Long-Term Safety and Tolerability of
the TAK-491 and Chlorthalidone Fixed-Dose Combination Versus Olmesartan Medoxomil and
Hydrochlorothiazide Fixed-Dose Combination in Hypertensive Subjects With Moderate Renal
Impairment

The primary objective of this study is to evaluate the long-term safety and tolerability of the TAK-491CLD FDC in comparison to the OLM/HCTZ FDC in hypertensive subjects with moderate renal impairment.

Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The objective of this extension study is to find out the potential long-term benefits and safety of tolvaptan. During this study all participants will receive tolvaptan.PRIMARY OBJECTIVE is to demonstrate whether tolvaptan modifies ADPKD progression…

An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects with Non-dialysis-dependent Chronic Kidney Disease

* To evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce erythropoiesis stimulating agent (ESA) use and/or other anaemia management options in NDD-CKD subjects with iron…

A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.

To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…

A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function

Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

A 24-month, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion (CRAD001A2429, ELEVATE study)

Primary objective: To demonstrate superior renal allograft function in de novo renal transplant recipients after early CNI to everolimus conversion assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease…

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 prospective, randomized, open, multicenter study to evaluate the efficacy and tolerability of induction therapy with a single high-dose anti-T-lymphocyte globulin (ATG-Fresenius) in renal transplant patients with a kidney from a non-heart-beating donor and tacrolimus, mycophenolate mofetil, and steroids as basic immunosuppression.

With an one-off infusion of anti-thymocyte globulin (ATG) during the operation the T-cell function is decreased. With this action we try to achieve that DGF does not occur or that the length of the DGF is as short as possible and less frequent…