Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

M.D. Anderson Cancer Center

Overview

This phase II trial studies how well arginine works in treating patients with kidney injury caused by anti-VEGF drugs used in standard treatment for cancer. Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to improve kidney function in patients.

PRIMARY OBJECTIVES: I. To assess the value and/or limitations of using orally supplemented arginine (L-arginine) to improve renal function associated with the use of anti-angiogenic therapies that target vascular endothelial growth factor (VEGF). OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive arginine orally (PO) four times daily (QID). Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. GROUP II: Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment patients are followed up within 1 month.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Drug-Induced Nephropathy Hypertension Proteinuria

Interventions

ArginineDIETARY_SUPPLEMENT

Given PO

PlaceboDRUG

Given PO

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * On or enrolled for anti-VEGF therapy * Systolic Blood Pressure \>= 140 mm Hg * Diastolic Blood Pressure \>= 90 mm Hg * Proteinuria \>= 500 mg/day or worsening glomerular filtration rate (GFR) (\> 0.3 mg/dl in 48 hours \[hrs.\] or \> 50% decline from baseline creatinine in 1 week) Exclusion Criteria: * Allergy to L-arginine * Systolic Blood Pressure \< 140 mm Hg * Diastolic Blood Pressure \< 90 mm Hg * Proteinuria \< 500 mg/day * Continuous tube feeds (since the medication will be given in-between meals)

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day

Linear mixed effects regression will be utilized to analyze the longitudinal change of UPC between treatment and placebo groups.

Time frame: Baseline up to 3 months

Secondary Outcomes

Improved glomerular filtration rate (GFR) >= 25%

Linear mixed effects regression will be utilized to analyze the GFR between treatment and placebo groups.

Time frame: Baseline up to 3 months

Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg

Linear mixed effects regression will be utilized to analyze the SBP between treatment and placebo groups.

Time frame: Baseline up to 3 months

Data from ClinicalTrials.gov

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