Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis

NCT01690039 — Completed, 170 participants, Insel Gruppe AG, University Hospital Bern

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Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers

Registry	NCT01690039
Status	Completed
Study type	Observational
Enrollment	170 (Actual)
Sponsor	Insel Gruppe AG, University Hospital Bern (Other)
Conditions	Acidosis, Renal Tubular, Nephrolithiasis, Vacuolar Proton-Translocating ATPases
Interventions	Furosemide-Fludrocortisone-Test (test for urinary acidification) (Drug)
Dates	start 2012-09-01, primary completion 2016-12-31, completion 2017-05-12, first posted 2012-09-21, last updated 2018-10-09
Locations	1 site in Switzerland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

Furosemide-Fludrocortisone-Test (test for urinary acidification) (Drug), also known as 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.

+Outcome measures

Primary outcomes

Capability of urinary acidification [Five to six hours]

Secondary outcomes

Polymorphisms in the ATP6V1 gene [12 months]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* One or more episodes of nephrolithiasis

Exclusion Criteria:

* Absence of informed consent
* All conditions affecting renal acidification
* Pregnancy
* Nursing

+Locations (1)

Facility	City	Country	Status
Department of Nephrology and Hypertension, Bern University Hospital	Bern	Switzerland

+Investigators

Daniel Fuster, Attending physician Nephrology, Principal investigator, Department of Nephrology and Hypertension, Bern University Hospital