Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803124
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

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.

Condition or disease Intervention/treatment Phase
Polycystic Kidney, Autosomal Dominant Drug: Tolvaptan Drug: Placebo Phase 3

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Arm Intervention/treatment
Active Comparator: Tolvaptan

Drug: Tolvaptan

1 tablet before renography

Drug: Tolvaptan
1 tablet before renography

Placebo Comparator: Placebo

Placebo

1 tablet before renography

Drug: Placebo
1 tablet before renography




Primary Outcome Measures :
  1. Renal plasma flow (RPF) [ Time Frame: Two hours after trial medicine intake ]
    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 :
  1. Central and brachial blood pressures (BP) [ Time Frame: Measured every 15 minutes during the examination day ]
    Measured using Mobil-O-Graph® PWA (unit of measurement= mmHg)

  2. Glomerular filtration rate (GFR) [ Time Frame: Two hours after trial medicine intake ]
    Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= ml/min)

  3. Filtration fraction (FF) [ Time Frame: Two hours after trial medicine intake ]
    Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= %)

  4. Plasma concentration of vasopressin (p-AVP) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood samples (unit of measurement= pg/ml)

  5. Plasma concentration of aldosterone (p-Aldo) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood samples (unit of measurement= pmol/ml)

  6. Plasma concentration of angiotensin II (p-AngII) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood samples (unit of measurement= pg/ml)

  7. Plasma concentration of renin (PRC) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood samples (unit of measurement= pg/ml)

  8. Urine excretion of aquaporin 2 (u-AQP2) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Urine sample (unit of measurement= ng/ml)

  9. Urine output (OU) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Urine sample (unit of measurement= ml/min)

  10. Urine osmolality (U-osm) [ Time Frame: measured before and 3 hours after trial medicine intake ]
    Urine sample (unit of measurement= mosmol/kg)

  11. Fractional excretion of sodium (FENa) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood and urine sample (unit of measurement= %)

  12. Albumin excretion rate [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood and urine sample (unit of measurement= mg/min)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803124


Locations
Layout table for location information
Denmark
Departments of medical research and medicine
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Layout table for investigator information
Principal Investigator: Frank Mose, MD, Ph D Departments of medical research and medicine

Layout table for additonal information
Responsible Party: Erling Bjerregaard Pedersen, Professor, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT03803124     History of Changes
Other Study ID Numbers: FHM-1-2015
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
CYSTS, KIDNEYS
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs