NCT02527863: TOPO

The Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Central Hemodynamics During Baseline Conditions and After Inhibition of the Nitric Oxide System in Patients With Autosomal Dominant Polycystic Kidney Disease

Completed Phase 2 Last updated 28 February 2017

What this trial tests

Phase 2 trial testing Tolvaptan in Autosomal Dominant Polycystic Kidney Disease in 18 participants. Completed in 1 August 2016.

Timeline

1 February 2015

Primary endpoint
1 August 2016

1 August 2016

Quick facts

Lead sponsor	Regional Hospital Holstebro
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	18
Start date	1 February 2015
Primary completion	1 August 2016
Estimated completion	1 August 2016
Sites	1 location across Denmark

Drugs / interventions tested

• Tolvaptan (TOLVAPTAN) — full drug profile →
• Placebo

Conditions studied

• Autosomal Dominant Polycystic Kidney Disease — all drugs for Autosomal Dominant Polycystic Kidney Disease →

Sponsor

Regional Hospital Holstebro

Who can join

Adults 18 to 65, any sex, with Autosomal Dominant Polycystic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• CH2O (Measurement of H2O clearance)
  Time frame: 5-6 Hours
  Measurement of H2O clearance at baseline, during and after L-NMMA infusion

Sponsor's own description

Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which stimulates V1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones.

The purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA) in patients with autosomal dominant polycystic kidney disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Experimental Models of Polycystic Kidney Disease: Applications and Therapeutic Testing.
   Sieben CJ, Harris PC. · · 2023 · cited 23× · PMID 37418622 · DOI 10.34067/kid.0000000000000209
2. Effect of tolvaptan on renal handling of water and sodium, GFR and central hemodynamics in autosomal dominant polycystic kidney disease during inhibition of the nitric oxide system: a randomized, placebo-controlled, double blind, crossover study.
   Al Therwani S, Malmberg MES, Rosenbaek JB, Bech JN, et al · · 2017 · cited 14× · PMID 28810844 · DOI 10.1186/s12882-017-0686-3