Status:
WITHDRAWN
Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hyperoxaluria
Eligibility:
All Genders
10-80 years
Phase:
PHASE3
Brief Summary
This study will test the effectiveness of two medications: ACEI (angiotensin converting enzyme inhibitor)and ARB (angiotensin receptor blocker) in reducing the renal injury induced by hyperoxaluria in...
Detailed Description
In patients with primary hyperoxaluria (PH), deficiency of hepatic enzymes important in disposition of glyoxylate results in marked hyperoxaluria. Calcium oxalate crystals and high oxalate concentrati...
Eligibility Criteria
Inclusion
- Diagnosis of PH established by liver enzyme analysis in the patient or an affected sibling, DNA testing for mutations of the AGXT and GR/HPR gene, or meeting clinical criteria (Urine oxalate \> 70 mg/1.73 m2/day in the absence of malabsorption or dietary excess of oxalate. Elevated urine glycolate or glycerate provides supporting evidence of type I or type II PH, respectively).
- Hyperoxaluria that persists during treatment with pyridoxine.
- Ten years of age or older.
- Glomerular filtration rate \> 50 ml/min/1.73 m2 at the start of the study.
- Women of child bearing age will be required to use adequate contraception for 3 months before and throughout the study.
- Patients will be on a stable program of pyridoxine, neutral phosphate, or citrate medications -
Exclusion
- a. Age \< 10 years. b. Glomerular filtration rate \< 50 at start of study c. Hypersensitivity to ACEI or ARB medications d. Chronic use of ACEI or ARB medications prior to enrollment e. Hyperkalemia f. Previous renal transplant g. Homozygosity for the G170R mutation of AGXT h. Unwillingness to use adequate contraception during the study. i. Pregnancy
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Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00280215
Start Date
December 1 2007
End Date
December 1 2011
Last Update
April 7 2015
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