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

Primary Purpose

Polycystic Kidney, Autosomal Dominant

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Tolvaptan
Placebo
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Polycystic Kidney, Autosomal Dominant focused on measuring CYSTS, KIDNEYS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departments of medical research and medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tolvaptan

Placebo

Arm Description

Drug: Tolvaptan 1 tablet before renography

Placebo 1 tablet before renography

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Central and brachial blood pressures (BP)
Measured using Mobil-O-Graph® PWA (unit of measurement= mmHg)
Glomerular filtration rate (GFR)
Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= ml/min)
Filtration fraction (FF)
Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= %)
Plasma concentration of vasopressin (p-AVP)
Blood samples (unit of measurement= pg/ml)
Plasma concentration of aldosterone (p-Aldo)
Blood samples (unit of measurement= pmol/ml)
Plasma concentration of angiotensin II (p-AngII)
Blood samples (unit of measurement= pg/ml)
Plasma concentration of renin (PRC)
Blood samples (unit of measurement= pg/ml)
Urine excretion of aquaporin 2 (u-AQP2)
Urine sample (unit of measurement= ng/ml)
Urine output (OU)
Urine sample (unit of measurement= ml/min)
Urine osmolality (U-osm)
Urine sample (unit of measurement= mosmol/kg)
Fractional excretion of sodium (FENa)
Blood and urine sample (unit of measurement= %)
Albumin excretion rate
Blood and urine sample (unit of measurement= mg/min)

Full Information

First Posted
January 7, 2019
Last Updated
January 10, 2019
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT03803124
Brief Title
Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
Acronym
POLY
Official Title
Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The aim is to measure the acute effects of tolvaptan on: Renal hemodynamics (RPF, GFR, filtration fraction ((FF)) and renovascular resistance ((RVR)) Blood pressure (central blood pressure ((cBP)) and brachial blood pressure bBP) Several vasoactive hormones (plasma renin ((PRC)), plasma angiotensin II ((p-Ang-II)), plasma aldosterone ((p-Aldo)), plasma vasopressin ((p-AVP)) in patients with ADPKD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney, Autosomal Dominant
Keywords
CYSTS, KIDNEYS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolvaptan
Arm Type
Active Comparator
Arm Description
Drug: Tolvaptan 1 tablet before renography
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tablet before renography
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Intervention Description
1 tablet before renography
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet before renography
Primary Outcome Measure Information:
Title
Renal plasma flow (RPF)
Description
Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= ml/min)
Time Frame
Two hours after trial medicine intake
Secondary Outcome Measure Information:
Title
Central and brachial blood pressures (BP)
Description
Measured using Mobil-O-Graph® PWA (unit of measurement= mmHg)
Time Frame
Measured every 15 minutes during the examination day
Title
Glomerular filtration rate (GFR)
Description
Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= ml/min)
Time Frame
Two hours after trial medicine intake
Title
Filtration fraction (FF)
Description
Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= %)
Time Frame
Two hours after trial medicine intake
Title
Plasma concentration of vasopressin (p-AVP)
Description
Blood samples (unit of measurement= pg/ml)
Time Frame
Measured before and 3 hours after trial medicine intake
Title
Plasma concentration of aldosterone (p-Aldo)
Description
Blood samples (unit of measurement= pmol/ml)
Time Frame
Measured before and 3 hours after trial medicine intake
Title
Plasma concentration of angiotensin II (p-AngII)
Description
Blood samples (unit of measurement= pg/ml)
Time Frame
Measured before and 3 hours after trial medicine intake
Title
Plasma concentration of renin (PRC)
Description
Blood samples (unit of measurement= pg/ml)
Time Frame
Measured before and 3 hours after trial medicine intake
Title
Urine excretion of aquaporin 2 (u-AQP2)
Description
Urine sample (unit of measurement= ng/ml)
Time Frame
Measured before and 3 hours after trial medicine intake
Title
Urine output (OU)
Description
Urine sample (unit of measurement= ml/min)
Time Frame
Measured before and 3 hours after trial medicine intake
Title
Urine osmolality (U-osm)
Description
Urine sample (unit of measurement= mosmol/kg)
Time Frame
measured before and 3 hours after trial medicine intake
Title
Fractional excretion of sodium (FENa)
Description
Blood and urine sample (unit of measurement= %)
Time Frame
Measured before and 3 hours after trial medicine intake
Title
Albumin excretion rate
Description
Blood and urine sample (unit of measurement= mg/min)
Time Frame
Measured before and 3 hours after trial medicine intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Mose, MD, Ph D
Organizational Affiliation
Departments of medical research and medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departments of medical research and medicine
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

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

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