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Report for Clinical Trial NCT00280215

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria

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.

NCT00280215 Hyperoxaluria
MeSH: Hyperoxaluria, Primary

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

1

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

1

Name: Placebo

Description: Patients will receive placebo for 24 months

Type: Drug

2


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