NCT03803124

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

January 7, 2019

Last Update Submit

January 10, 2019

Conditions

Polycystic Kidney, Autosomal Dominant

Keywords

CYSTS, KIDNEYS

Outcome Measures

Primary Outcomes (1)

  • Renal plasma flow (RPF)

    Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= ml/min)

    Two hours after trial medicine intake

Secondary Outcomes (12)

  • Central and brachial blood pressures (BP)

    Measured every 15 minutes during the examination day

  • Glomerular filtration rate (GFR)

    Two hours after trial medicine intake

  • Filtration fraction (FF)

    Two hours after trial medicine intake

  • Plasma concentration of vasopressin (p-AVP)

    Measured before and 3 hours after trial medicine intake

  • Plasma concentration of aldosterone (p-Aldo)

    Measured before and 3 hours after trial medicine intake

  • +7 more secondary outcomes

Study Arms (2)

Tolvaptan

ACTIVE COMPARATOR

Drug: Tolvaptan 1 tablet before renography

Drug: Tolvaptan

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet before renography

Drug: Placebo

Interventions

TolvaptanDRUG

1 tablet before renography

Tolvaptan
PlaceboDRUG

1 tablet before renography

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of medical research and medicine

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantCysts

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, InbornNeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Frank Mose, MD, Ph D

    Departments of medical research and medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 14, 2019

Study Start

December 1, 2015

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

DK(1)