NL-OMON51229
Completed
Phase 3
Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-EXT - LTS15823
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Genzyme Europe BV
- 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 who has completed the treatment period in
- •Stage 1 or Stage 2 of Study EFC15392\.
- •\- The patient has an eGFR \>30 mL/min/1\.73 m2:
- •a) measured at Visit 11 of the EFC15392 study for participant enrolled in the
- •LTS15823 study at the time of Visit 12 (Month 24; end\-of treatment visit) of
- •the EFC15392 study.
- •b) measured at Screening visit for participant enrolled in the LTS15823 study
- •not concomitantly to the Visit 12 (Month 24; end\-of treatment visit) of the
- •EFC15392 study.
- •\- Contraceptive use by men and women should be consistent with local
Exclusion Criteria
- •For participants who have lag phase between the end of the EFC15392 study and
- •Screening visit (Visit 0\) in the LTS15823 study:
- •\-The patient has a new clinically significant, uncontrolled medical condition
- •that, in the opinion of the Investigator, would put the safety of the patient
- •at risk through participation, or which would affect the efficacy or safety
- •analysis if the condition exacerbated during the study, or that may
- •significantly interfere with study compliance, including all prescribed
- •evaluations and follow\-up activities.
- •\-A history of drug abuse and/or alcohol abuse or alcohol dependence during the
- •lag phase between the end of the EFC15392 study and Screening visit (Visit 0\)
Outcomes
Primary Outcomes
Not specified
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