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Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study category: Kidney Disease & Hypertension

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Description

This is an international, multicenter trial. Participants will be given either active study drug or placebo and will be followed for a period of 2 years.

Details
Age

Adult

Eligibility

Male or female adult with ADPKD between the ages of 18 to 50. Estimated glomerular filtration rate between 45 to 90 mL/min/1.73 m2. Systolic blood pressure <160. Should not be taking Tolvaptan within 3 months of screening visit.

Phase

II/III - A combination of phases: (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. and (3) Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Michel Chonchol,  MD

Michel Chonchol, MD

Study ID

Protocol Number: 18-1842

More information available at ClinicalTrials.gov: NCT03523728

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