Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib...
Autosomal Dominant Polycystic Kidney Disease (ADPKD)Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
Autosomal Dominant Polycystic KidneyADPKDThis international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.
A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney...
Autosomal Dominant Polycystic Kidney DiseaseThis is an exploratory, randomized, double-blind, placebo-controlled, parallel group, multicenter, proof of concept study (Phase 2a), evaluating orally administered GLPG2737 for a double-blind (DB) treatment period of 52 weeks and 4 weeks of follow up as well as an open-label extension (OLE) treatment period of 52 weeks and 4 weeks of follow-up, in subjects with rapidly progressing ADPKD.
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic...
Polycystic Kidney DiseaseAdult1 moreThis is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Up to 50 eligible participants will be enrolled and treated with lixivaptan for 52 weeks following titration to an optimal dose.
Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat
Congenital Cystic Kidney DiseasePrimary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). Secondary Objective: To determine the effect of early versus delayed treatment with venglustat on the renal function (estimated glomerular filtration rate [eGFR] [Chronic Kidney Disease Epidemiology Collaboration {CKD-EPI} equation]). To characterize the safety profile of venglustat. To evaluate the effect of venglustat on the lens by ophthalmological examination. To evaluate the effect of venglustat on mood using Beck Depression Inventory-II (BDI-II).
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
Chronic Kidney DiseasesAlport Syndrome1 moreThis extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.
Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency
Autosomal Dominant Polycystic Kidney Disease (ADPKD)The general aim of this study in adult patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and severe renal insufficiency is to assess the safety and the efficacy of sirolimus (SRL) in slowing renal function decline as compared to conventional therapy.
A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD...
Polycystic KidneyAutosomal DominantPrimary Objective: To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2). Secondary Objectives: To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2). To evaluate the pharmacokinetics (PK) of venglustat in ADPKD participants (Stages 1 and 2). To determine the effect of venglustat on pain and fatigue, based on participant reported diary (Stages 1 and 2). Safety/tolerability objectives: To characterize the safety profile of venglustat (Stages 1 and 2). To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2). To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).
Everolimus on CKD Progression in ADPKD Patients
Polycystic Kidney DiseasesThe study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.
Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers...
Autosomal Dominant Polycystic Kidney DiseaseCurrently the only approved use for rapamycin (sirolimus) is for immunosuppression after renal transplantation. This trial is designed to determine whether rapamycin is safe and effective treatment for patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and urine samples will also be collected to evaluate for change in biomarkers with treatment.