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

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01690039
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Duration (Months): 56.3
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acidosis, Renal Tubular; Nephrolithiasis; Vacuolar Proton-Translocating ATPases	Drug: Furosemide-Fludrocortisone-Test (test for urinary acidification)

Study Design

• Study Type: Observational
• Actual Enrollment: 170 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: May 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
All study participants Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients.	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 Names: Application of Furosemide (Lasix® ) and Fludrocortisone (Florinef®)

Outcome Measures

Primary Outcome Measures

1. Capability of urinary acidification [Five to six hours]

Secondary Outcome Measures

1. Polymorphisms in the ATP6V1 gene [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• One or more episodes of nephrolithiasis

Exclusion Criteria:

• Absence of informed consent

• All conditions affecting renal acidification

• Pregnancy

• Nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nephrology and Hypertension, Bern University Hospital	Bern		Switzerland	3010

Sponsors and Collaborators

• University Hospital Inselspital, Berne

Investigators

• Principal Investigator: Daniel Fuster, Attending physician Nephrology, Department of Nephrology and Hypertension, Bern University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Institution homepage

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT01690039
• Other Study ID Numbers: 090/12
• First Posted: Sep 21, 2012
• Last Update Posted: Oct 9, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by University Hospital Inselspital, Berne: renal tubular acidosis; V-ATPase; kidney stones
• Additional relevant MeSH terms: Nephrolithiasis; Kidney Calculi; Acidosis, Renal Tubular; Acidosis; Fludrocortisone; Furosemide

Study Results

No Results Posted as of Oct 9, 2018