NL-OMON50604
Completed
Phase 2
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) - STAGED-PKD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ADPKD
- Sponsor
- Sanofi-aventis
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female adult with ADPKD:
- •a) between ages of 18 and 50 years (inclusive) for patients in Stage 1
- •b) between 18 and 50 years (inclusive) for patients in Stage 2 with an eGFR
- •between 45 and 89\.9 mL/min/1\.73 m2 during the screening period
- •c) between 18 and 55 years (inclusive) for patients in Stage 2 with an eGFR
- •between 30 and 44\.9 mL/min/1\.73 m2 during the screening period
- •Diagnosis of ADPKD in patients with a family history, will be based on unified
- •Pei criteria. In the absence of a family history, the diagnosis will be based
- •on the presence of renal cysts bilaterally, totaling at least 20, in the
- •absence of findings suggestive of other cystic renal diseases.
Exclusion Criteria
- •\- Systolic BP \>160 mmHg at run\-in and baseline visits.
- •\- History of administration of tolvaptan or other Polycystic Kidney
- •Disease\-modifying agents (somatostatin analogues) within 3 months prior to the
- •screening visit.
- •\- The patient, in the opinion of the Investigator, is unable to adhere to the
- •requirements of the study or unable to undergo study assessments (eg, has
- •contraindications to pupillary dilation or unable to undergo magnetic resonance
- •imaging \[MRI] \[For example: patient\*s weight exceeds weight capacity of the
- •MRI, ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia,
- •large abdominal/back tattoos, etc]).
Outcomes
Primary Outcomes
Not specified
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