Nephrolithiasis, Calcium OxalatePhase 1NCT02096965
Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study
A Phase 1 study testing Tolvaptan in people with Nephrolithiasis, Calcium Oxalate and Nephrolithiasis, Calcium Phosphate, run by Mayo Clinic at 1 site in United States.
Trial summary
In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate
- What is being tested?
- Tolvaptan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2015
- Phase
- Phase 1
- 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
- History of calcium oxalate or calcium phosphate stone.
- Good renal function
Who cannot join
- History of hypo-or hypernatremia.
- History of hypotension or orthostatic dizziness.
- Clinical history of congestive heart failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night. To this end, a higher dose is used in the morning, with a lower dose in the afternoon.
- Being tested
- Tolvaptan, Placebo
- Keywords
- Calcium oxalate, Calcium phosphate, Kidney stone
- Medical subject headings
- Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
PlaceboDrug
Patients will receive daily dose at 8 AM and at 4 PM.
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan first, then Placebo | Experimental | Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period) Receives: Drug: Tolvaptan; Drug: Placebo |
| Placebo first, then Tolvaptan | Experimental | Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period) Receives: Drug: Tolvaptan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary calcium oxalate supersaturation (SS)
Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers.
Measured: Baseline to 3 weeks
Change in Calcium phosphate SS
Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers.
Measured: Baseline to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrolithiasis, Calcium OxalateStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- 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
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lieske, Mayo Clinic
- Investigators
- John Lieske, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096965
- Sponsor's protocol ID
- 11-001780
- Status last verified
- Mar 2016
- First submitted
- 24 Mar 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study
- ClinicalTrials.gov ID
- NCT02096965
- Acronym / sponsor ID
- 11-001780
- Keywords
- Calcium oxalate, Calcium phosphate, Kidney stone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night. To this end, a higher dose is used in the morning, with a lower dose in the afternoon.
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 first, then Placebo | Experimental | Drug: Tolvaptan, Drug: PlaceboTolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period) |
| Placebo first, then Tolvaptan | Experimental | Drug: Tolvaptan, Drug: PlaceboPlacebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of calcium oxalate or calcium phosphate stone.
- Good renal function
Key exclusion criteria (3 listed)
- History of hypo-or hypernatremia.
- History of hypotension or orthostatic dizziness.
- Clinical history of congestive heart failure.
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 |
|---|---|---|
| TolvaptanAlso: SamscaPatients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). | Drug | Placebo first, then Tolvaptan, Tolvaptan first, then Placebo |
| PlaceboPatients will receive daily dose at 8 AM and at 4 PM. | Drug | Placebo first, then Tolvaptan, Tolvaptan first, then Placebo |
Primary outcome
Change in urinary calcium oxalate supersaturation (SS)
Time frame: Baseline to 3 weeks
Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers.
Change in Calcium phosphate SS
Time frame: Baseline to three weeks
Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers.
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 30 Mar 2016.
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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.
John Lieske, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolvaptan in people with Nephrolithiasis, Calcium Oxalate and Nephrolithiasis, Calcium Phosphate, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 3 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 30 Mar 2016. 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 United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in urinary calcium oxalate supersaturation (SS) (time frame: Baseline to 3 weeks). The study lists 2 primary outcomes in all. 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 30 Mar 2016.