Acidosis, Renal TubularNCT01690039
Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
An observational study of Acidosis, Renal Tubular and Nephrolithiasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Purpose 1. To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test. 2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acidosis, Renal Tubular, Nephrolithiasis, Vacuolar Proton-Translocating ATPases
- What is being tested?
- Furosemide-Fludrocortisone-Test (test for urinary acidification)
- How many people
- 170 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to 12 May 2017
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffered from at least one kidney stone episode.
Who may be able to join
- One or more episodes of nephrolithiasis
Who cannot join
- Absence of informed consent
- All conditions affecting renal acidification
- Pregnancy
- Nursing
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Nephrology and Hypertension, Bern University Hospital
Bern, 3010
About this study
Official title: Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers
Purpose
- To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.
- To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.
- Being tested
- Furosemide-Fludrocortisone-Test (test for urinary acidification)
- Keywords
- renal tubular acidosis, V-ATPase, kidney stones
- Medical subject headings
- Acidosis, Renal Tubular, Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide-Fludrocortisone-Test (test for urinary acidification)Drug
Also called Application of Furosemide (Lasix® ) and Fludrocortisone (Florinef®)
The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients. Receives: Drug: Furosemide-Fludrocortisone-Test (test for urinary acidification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capability of urinary acidification
Measured: Five to six hours
Secondary outcomes (1)
Polymorphisms in the ATP6V1 gene
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion31 Dec 2016
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acidosis, Renal TubularStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Fuster, Attending physician Nephrology, Principal investigator, Department of Nephrology and Hypertension, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690039
- Sponsor's protocol ID
- 090/12
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2012
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers
- ClinicalTrials.gov ID
- NCT01690039
- Acronym / sponsor ID
- 090/12
- Keywords
- renal tubular acidosis, V-ATPase, kidney stones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 21 Sep 2012 (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.
Purpose
- To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.
- To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Drug: Furosemide-Fludrocortisone-Test (test for urinary acidification)Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffered from at least one kidney stone episode.
Key inclusion criteria (1 listed)
- One or more episodes of nephrolithiasis
Key exclusion criteria (4 listed)
- Absence of informed consent
- All conditions affecting renal acidification
- 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 |
|---|---|---|
| Furosemide-Fludrocortisone-Test (test for urinary acidification)Also: Application of Furosemide (Lasix® ) and Fludrocortisone (Florinef®)The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients. | Drug | All study participants |
Primary outcome
Capability of urinary acidification
Time frame: Five to six hours
1 secondary outcome
Polymorphisms in the ATP6V1 gene
Time frame: 12 months
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 9 Oct 2018.
- Institution homepageLink provided by the sponsor.
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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.
Daniel Fuster, Attending physician Nephrology principal investigator
Department of Nephrology and Hypertension, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acidosis, Renal Tubular and Nephrolithiasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 4 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 9 Oct 2018. 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 Switzerland. 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.
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?
Capability of urinary acidification (time frame: Five to six hours). 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 9 Oct 2018.