- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690039
Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
October 8, 2018 updated by: University Hospital Inselspital, Berne
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
170
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bern, Switzerland, 3010
- Department of Nephrology and Hypertension, Bern University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients suffered from at least one kidney stone episode.
Description
Inclusion Criteria:
- One or more episodes of nephrolithiasis
Exclusion Criteria:
- Absence of informed consent
- All conditions affecting renal acidification
- Pregnancy
- Nursing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All study participants
Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients.
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The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Capability of urinary acidification
Time Frame: Five to six hours
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Five to six hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Polymorphisms in the ATP6V1 gene
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Fuster, Attending physician Nephrology, Department of Nephrology and Hypertension, Bern University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
May 12, 2017
Study Registration Dates
First Submitted
September 10, 2012
First Submitted That Met QC Criteria
September 17, 2012
First Posted (Estimate)
September 21, 2012
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 8, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Genetic Diseases, Inborn
- Pathological Conditions, Anatomical
- Renal Tubular Transport, Inborn Errors
- Urolithiasis
- Urinary Calculi
- Calculi
- Acid-Base Imbalance
- Kidney Calculi
- Nephrolithiasis
- Acidosis
- Acidosis, Renal Tubular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
- Fludrocortisone
Other Study ID Numbers
- 090/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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