Overview

Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria

Status:
Withdrawn
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Lisinopril
Losartan
Criteria
Inclusion Criteria:

1. 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).

2. Hyperoxaluria that persists during treatment with pyridoxine.

3. Ten years of age or older.

4. Glomerular filtration rate > 50 ml/min/1.73 m2 at the start of the study.

5. Women of child bearing age will be required to use adequate contraception for 3 months
before and throughout the study.

6. 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

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