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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01690039
First received: September 10, 2012
Last updated: November 24, 2016
Last verified: November 2016

September 10, 2012
November 24, 2016
September 2012
September 2017   (final data collection date for primary outcome measure)
Capability of urinary acidification [ Time Frame: Five to six hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01690039 on ClinicalTrials.gov Archive Site
Polymorphisms in the ATP6V1 gene [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood
Non-Probability Sample
Patients suffered from at least one kidney stone episode.
  • Acidosis, Renal Tubular
  • Nephrolithiasis
  • Vacuolar Proton-Translocating ATPases
Drug: Furosemide-Fludrocortisone-Test (test for urinary acidification)
The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients.
Other Name: Application of Furosemide (Lasix® ) and Fludrocortisone (Florinef®)
All study participants
Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients.
Intervention: Drug: Furosemide-Fludrocortisone-Test (test for urinary acidification)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2017
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • One or more episodes of nephrolithiasis

Exclusion Criteria:

  • Absence of informed consent
  • All conditions affecting renal acidification
  • Pregnancy
  • Nursing
Both
18 Years and older   (Adult, Senior)
Yes
Contact: Daniel Fuster, Attending physician Nephrology ++41 (0)31 631 37 49 daniel.fuster@ibmm.unibe.ch
Contact: Nasser Dhayat, Resident Nephrology ++41 (0)31 632 31 44 nasser.dhayat@insel.ch
Switzerland
 
NCT01690039
090/12
No
Not Provided
Not Provided
University Hospital Inselspital, Berne
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Daniel Fuster, Attending physician Nephrology Department of Nephrology and Hypertension, Bern University Hospital
University Hospital Inselspital, Berne
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP