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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.
The aim is to measure the acute effects of tolvaptan on:
in patients with ADPKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Active Comparator | Drug: Tolvaptan 1 tablet before renography |
|
| Placebo | Placebo Comparator | Placebo 1 tablet before renography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | 1 tablet before renography |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Central and brachial blood pressures (BP) | Measured using Mobil-O-Graph® PWA (unit of measurement= mmHg) | Measured every 15 minutes during the examination day |
| Glomerular filtration rate (GFR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Mose, MD, Ph D | Departments of medical research and medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of medical research and medicine | Holstebro | 7500 | Denmark |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D003560 | Cysts |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
1 tablet before renography |
|
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 |
| 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= %) | Two hours after trial medicine intake |
| Plasma concentration of vasopressin (p-AVP) | Blood samples (unit of measurement= pg/ml) | Measured before and 3 hours after trial medicine intake |
| Plasma concentration of aldosterone (p-Aldo) | Blood samples (unit of measurement= pmol/ml) | Measured before and 3 hours after trial medicine intake |
| Plasma concentration of angiotensin II (p-AngII) | Blood samples (unit of measurement= pg/ml) | Measured before and 3 hours after trial medicine intake |
| Plasma concentration of renin (PRC) | Blood samples (unit of measurement= pg/ml) | Measured before and 3 hours after trial medicine intake |
| Urine excretion of aquaporin 2 (u-AQP2) | Urine sample (unit of measurement= ng/ml) | Measured before and 3 hours after trial medicine intake |
| Urine output (OU) | Urine sample (unit of measurement= ml/min) | Measured before and 3 hours after trial medicine intake |
| Urine osmolality (U-osm) | Urine sample (unit of measurement= mosmol/kg) | measured before and 3 hours after trial medicine intake |
| Fractional excretion of sodium (FENa) | Blood and urine sample (unit of measurement= %) | Measured before and 3 hours after trial medicine intake |
| Albumin excretion rate | Blood and urine sample (unit of measurement= mg/min) | Measured before and 3 hours after trial medicine intake |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |