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Report for Clinical Trial NCT00280215
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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 patients with Primary Hyperoxaluria.
Hypothesis: Calcium oxalate crystal deposition in the kidney causes inflammation and
resulting injury to kidney tissue. Angiotensin blockade will improve these changes, thus
slowing the progression of renal insufficiency in patients with Primary Hyperoxaluria.
3 Interventions
Name: ACEI / Angiotensin converting enzyme inhibitor
Description: 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.
Type: Drug
Name: ARB /Angiotensin Receptor Blocker
Description: 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.
Type: Drug
Name: Placebo
Description: Patients will receive placebo for 24 months
Type: Drug
Primary Outcomes
Measure: Two-year change in the urinary markers of renal tubular injury and interstitial fibrosis Time: 2 years
Secondary Outcomes
Measure: Rate of change in 1. Renal tubular injury markers and 2. Renal function as determined by serum creatinine and creatinine clearance. Time: 2 years
Purpose: Prevention
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 G170R
Homozygosity for the G170R mutation of AGXT h. --- G170R ---
HPO Nodes