Hyperoxaluria Clinical Trial
Official title:
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.
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 concentrations in the renal filtrate result in inflammation and injury in the renal
parenchyma. Loss of renal function over time is characteristic, with end stage renal failure
occurring in half the patients by age 35 years, but as early as infancy in some patients.
Experience in animal models of hyperoxaluria, and from other renal diseases, supports a role
for ACEI and ARB medications in ameliorating inflammation and injury thus providing a renal
protective effect.
We propose to study the short-term effect of combined angiotensin converting enzyme
inhibitor (ACEI) and angiotensin receptor blocking (ARB) therapy in patients with PH, in a
controlled, randomized, two-year study. Primary endpoints will be urinary markers of renal
tubular injury (retinol binding protein (RBP), alpha 1 microglobulin (α1m), γ-glutamyl
transferase (GGT)) and interstitial fibrosis (transforming growth factor beta 1 (TGFβ1).
Secondary endpoints will be the rates of change in renal tubular injury and renal function
as determined by serum creatinine and creatinine clearance.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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