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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-15

Brief Summary

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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.

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Detailed Description

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The aim is to measure the acute effects of tolvaptan on:

1. Renal hemodynamics (RPF, GFR, filtration fraction ((FF)) and renovascular resistance ((RVR))
2. Blood pressure (central blood pressure ((cBP)) and brachial blood pressure bBP)
3. Several vasoactive hormones (plasma renin ((PRC)), plasma angiotensin II ((p-Ang-II)), plasma aldosterone ((p-Aldo)), plasma vasopressin ((p-AVP))

in patients with ADPKD.

Conditions

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Polycystic Kidney, Autosomal Dominant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tolvaptan

Drug: Tolvaptan

1 tablet before renography

Group Type ACTIVE_COMPARATOR

Tolvaptan

Intervention Type DRUG

1 tablet before renography

Placebo

Placebo

1 tablet before renography

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet before renography

Interventions

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Tolvaptan

1 tablet before renography

Intervention Type DRUG

Placebo

1 tablet before renography

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Diagnosis with ADPKD
* Informed consent
* Contraception for fertile women

Exclusion Criteria

* Renal transplantation
* Operation in the kidney
* Diabetes mellitus
* Neoplastic conditions
* Pregnancy, nursing
* Unwillingness to participate
* eGFR \> 30
* Intolerance towards tolvaptan
* Alcohol or medical abuse,
* BP \>\>170/110 blood pressure despite regulation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No