drugset / Trial / NCT03596957

Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

NCT03596957

Phase 4 Unknown 90 enrolled Lisbet Brandi
RandomizedParallel-groupSingle-blindTreatment

Summary

Investigator initiated controlled multi-centre trial in a Prospective, Randomised, Open, Blinded Endpoint (PROBE) design. Patients will be randomised in a 1:1 ratio either to treatment with tolvaptan for six weeks followed by six weeks observation without trial medication or no tolvaptan treatment, but following the same visit and investigation plan as the subjects taking tolvaptan.

Timeline

Start
2018-09-12
Primary completion
2019-06
Completion
2020-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tolvaptan Small molecule 30 mg
Comparator Tolvaptan Small molecule 90 mg