Polycystic Kidney, Autosomal DominantPhase 3POLYNCT03803124
Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
A Phase 3 study testing Tolvaptan in people with Polycystic Kidney, Autosomal Dominant, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2015to 15 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Diagnosis with ADPKD
- Informed consent
- Contraception for fertile women
Who cannot join
- Renal transplantation
- Operation in the kidney
- Diabetes mellitus
- Neoplastic conditions
- Pregnancy, nursing
- Unwillingness to participate
Show all 10Show fewer
- eGFR > 30
- Intolerance towards tolvaptan
- Alcohol or medical abuse,
- BP >>170/110 blood pressure despite regulation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Being tested
- Tolvaptan, Placebo
- Keywords
- CYSTS, KIDNEYS
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
1 tablet before renography
PlaceboDrug
1 tablet before renography
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan | Active comparator | Drug: Tolvaptan
1 tablet before renography Receives: Drug: Tolvaptan |
| Placebo | Placebo comparator | Placebo
1 tablet before renography Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Two hours after trial medicine intake
Secondary outcomes (12)
Central and brachial blood pressures (BP)
Measured using Mobil-O-Graph® PWA (unit of measurement= mmHg)
Measured: Measured every 15 minutes during the examination day
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)
Measured: 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= %)
Measured: Two hours after trial medicine intake
Plasma concentration of vasopressin (p-AVP)
Blood samples (unit of measurement= pg/ml)
Measured: Measured before and 3 hours after trial medicine intake
Plasma concentration of aldosterone (p-Aldo)
Blood samples (unit of measurement= pmol/ml)
Measured: Measured before and 3 hours after trial medicine intake
Plasma concentration of angiotensin II (p-AngII)
Blood samples (unit of measurement= pg/ml)
Measured: Measured before and 3 hours after trial medicine intake
Plasma concentration of renin (PRC)
Blood samples (unit of measurement= pg/ml)
Measured: Measured before and 3 hours after trial medicine intake
Urine excretion of aquaporin 2 (u-AQP2)
Urine sample (unit of measurement= ng/ml)
Measured: Measured before and 3 hours after trial medicine intake
Urine output (OU)
Urine sample (unit of measurement= ml/min)
Measured: Measured before and 3 hours after trial medicine intake
Urine osmolality (U-osm)
Urine sample (unit of measurement= mosmol/kg)
Measured: measured before and 3 hours after trial medicine intake
Fractional excretion of sodium (FENa)
Blood and urine sample (unit of measurement= %)
Measured: Measured before and 3 hours after trial medicine intake
Albumin excretion rate
Blood and urine sample (unit of measurement= mg/min)
Measured: Measured before and 3 hours after trial medicine intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study startDec 2015
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney, Autosomal DominantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Frank Mose, MD, Ph D, Principal investigator, Departments of medical research and medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803124
- Sponsor's protocol ID
- FHM-1-2015
- Acronym
- POLY
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
- ClinicalTrials.gov ID
- NCT03803124
- Acronym / sponsor ID
- POLY / FHM-1-2015
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Keywords
- CYSTS, KIDNEYS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolvaptan | Active comparator | Drug: TolvaptanDrug: Tolvaptan 1 tablet before renography |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 tablet before renography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Diagnosis with ADPKD
- Informed consent
- Contraception for fertile women
Key exclusion criteria (10 listed)
- Renal transplantation
- Operation in the kidney
- Diabetes mellitus
- Neoplastic conditions
- Pregnancy, nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolvaptan1 tablet before renography | Drug | Tolvaptan |
| Placebo1 tablet before renography | Drug | Placebo |
Primary outcome
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)
12 secondary outcomes
Central and brachial blood pressures (BP)
Time frame: Measured every 15 minutes during the examination day
Glomerular filtration rate (GFR)
Time frame: Two hours after trial medicine intake
Filtration fraction (FF)
Time frame: Two hours after trial medicine intake
Plasma concentration of vasopressin (p-AVP)
Time frame: Measured before and 3 hours after trial medicine intake
Plasma concentration of aldosterone (p-Aldo)
Time frame: Measured before and 3 hours after trial medicine intake
Plasma concentration of angiotensin II (p-AngII)
Time frame: Measured before and 3 hours after trial medicine intake
Plasma concentration of renin (PRC)
Time frame: Measured before and 3 hours after trial medicine intake
Urine excretion of aquaporin 2 (u-AQP2)
Time frame: Measured before and 3 hours after trial medicine intake
Urine output (OU)
Time frame: Measured before and 3 hours after trial medicine intake
Urine osmolality (U-osm)
Time frame: measured before and 3 hours after trial medicine intake
Fractional excretion of sodium (FENa)
Time frame: Measured before and 3 hours after trial medicine intake
Albumin excretion rate
Time frame: Measured before and 3 hours after trial medicine intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Mose, MD, Ph D principal investigator
Departments of medical research and medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolvaptan in people with Polycystic Kidney, Autosomal Dominant, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal plasma flow (RPF) (time frame: Two hours after trial medicine intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.