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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.

PROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER

- To evaluate the bladder-preservation rate after chemoradiation - To evaluate the toxicity and complications of treatment with induction chemotherapy followed by ePLND and chemoradiation

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 (…

The efficacy of an antigenic marker lesion for the therapeutic effect in patients with multiple, Ta/T1, G1/G2, non-muscle invasive bladder cancer (NMIBC) treated with TUR followed by IL-2 instillation

We like to demonstrate that treatment of non-muscle invasive bladder carcinoma with incomplete TUR and IL-2 is therapeutically more effective than treatment with complete TUR and IL-2.

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-
Controlled, Multi-center Study to Evaluate the Efficacy, Safety and
Tolerability of Combinations of Solifenacin Succinate and Mirabegron
Compared to Solifenacin Succinate and Mirabegron Monotherapy in the
Treatment of Overactive Bladder

Primary objective *To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron compared to solifenacin and mirabegron monotherapySecondary objectives*To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron…

A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease

The primary objective of this trial is to evaluate and describe the long-term safety of tolvaptan.

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…

Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer

- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.- Secondary study objectives: Establish and compare…

A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of
the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy

The study objective is to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine or the onset of end stage renal disease (ESRD) in subjects with type 2 diabetes and nephropathy who are treated with the…

A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys from donors older than 50 years of age and donated after circulatory death.

To compare the effect of oxygenated versus non-oxygenated hypothermic machine perfusion of grafts of DCD category III (awaiting circulatory death - controlled), kidneys aged 50 years or older on kidney graft function.

Near-infrared Fluorescence-Enhanced Identification of the Ureters using ZW800-1

Primary objectives: To assess the feasibility of ZW800-1 in intraoperative detection of the urinary tract using the NIR fluorescence imaging system. Secondary objectives: To define the optimal dose of ZW800-1 for intraoperative imaging of the…

SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY

PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…

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 multi-center randomized, open label, controlled study in primary liver transplantation comparing long term renal function in recipients treated with standard dose extended release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus.

To evaluate the effectiveness and safety of concentration controlled combination of once daily dosed low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels:3-5 ng/ml), in order to provide superior renal function…

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…

An Open-label Trial Investigating the Association Between Nocturia Symptoms and Sleep During 12 Weeks of Treatment with desmopressin ODT for Nocturia due to Nocturnal Polyuria in Adults

Primary Objective* To assess the association between changes in the number of nocturnal voids and change in Nocturia Sleep Quality Scale (NSQS) total score in adult subjects with nocturia due to Nocturnal Polyuria (NP)Secondary Objectives* To assess…

Efficacy of rituximab in comparison to continued corticosteroid treatment in idiopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisone.

To evalute the efficacy of rituximab in comparison to continued corticosteroid treatment in ipatients with diopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisolone.