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

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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

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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)
  • 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)
  • 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= %)
  • Plasma concentration of vasopressin (p-AVP) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood samples (unit of measurement= pg/ml)
  • Plasma concentration of aldosterone (p-Aldo) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood samples (unit of measurement= pmol/ml)
  • 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)
  • Plasma concentration of renin (PRC) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood samples (unit of measurement= pg/ml)
  • 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)
  • Urine output (OU) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Urine sample (unit of measurement= ml/min)
  • Urine osmolality (U-osm) [ Time Frame: measured before and 3 hours after trial medicine intake ]
    Urine sample (unit of measurement= mosmol/kg)
  • Fractional excretion of sodium (FENa) [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood and urine sample (unit of measurement= %)
  • Albumin excretion rate [ Time Frame: Measured before and 3 hours after trial medicine intake ]
    Blood and urine sample (unit of measurement= mg/min)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
Official Title  ICMJE Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Polycystic Kidney, Autosomal Dominant
Intervention  ICMJE
  • Drug: Tolvaptan
    1 tablet before renography
  • Drug: Placebo
    1 tablet before renography
Study Arms  ICMJE
  • Active Comparator: Tolvaptan

    Drug: Tolvaptan

    1 tablet before renography

    Intervention: Drug: Tolvaptan
  • Placebo Comparator: Placebo

    Placebo

    1 tablet before renography

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03803124
Other Study ID Numbers  ICMJE FHM-1-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erling Bjerregaard Pedersen, Regional Hospital Holstebro
Study Sponsor  ICMJE Regional Hospital Holstebro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frank Mose, MD, Ph D Departments of medical research and medicine
PRS Account Regional Hospital Holstebro
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP