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Completed

NCT Number: NCT03803124

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

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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Key information

Conditions

Polycystic Kidney, Autosomal Dominant Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polycystic Kidney Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Departments of medical research and medicine

Holstebro, 7500, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tolvaptan

Drug

1 tablet before renography

Placebo

Drug

1 tablet before renography

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Acronym: POLY

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2019
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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