Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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L-Arginine For Anti-VEGF Induced Kidney Injury

Conditions
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Drug-Induced Nephropathy, Hypertension, Proteinuria

Intervention / Treatment
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* Dietary Supplement: Arginine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (arginine)<br>Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. | Dietary Supplement: Arginine<br>* Given PO<br>* Other names: L-Arginine;|
| Placebo Comparator: Group II (placebo)<br>Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. | Drug: Placebo<br>* Given PO<br>* Other names: sham therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved glomerular filtration rate (GFR) >= 25% | Linear mixed effects regression will be utilized to analyze the GFR between treatment and placebo groups. | 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. | Baseline up to 3 months |