Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria
Hyperoxaluria
About this trial
This is an interventional prevention trial for Hyperoxaluria focused on measuring Primary Hyperoxaluria
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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 -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
1
2
Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker. Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
Patients will take placebo for 24 months.