drugset / Trial / NCT03803124

Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD

NCT03803124

Phase 3 Completed 20 enrolled Regional Hospital Holstebro
RandomizedCrossoverTriple-blindBasic science

Summary

Polycystic kidney disease (ADPKD) is a common genetic disorder, characterized by the formation of cysts in the kidneys, causing gradual renal function-loss. Previous studies have shown that, reduced glomerular filtration rate (GFR) and renal plasma flow (RPF) play a role in the progression of renal disease in ADPKD. Tolvaptan is a vasopressin 2 antagonist, which seems to reduce the growth of total kidney volume (TKV) and the decline in e-GFR in ADPKD. The mechanism is not fully understood and could, at least partly, be caused by stimulation of the renal blood flow. The purpose of this trial is to investigate if tolvaptan´s improve renal blood flow and glomerular filtration in ADPKD, in a randomized, cross-over, double-blind, placebo-controlled study.

Timeline

Start
2015-12
Primary completion
2017-12-15
Completion
2017-12-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tolvaptan Small molecule