Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

Phase 2

Withdrawn

• Conditions: Drug-Induced Nephropathy; Hypertension; Proteinuria
• Interventions: Dietary Supplement: Arginine; Drug: Placebo

• Registration Number: NCT02882373
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-29
• Study Start: 2018-10-23
• Status Verified: 2019-05
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (arginine)	Arginine	Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
Group II (placebo)	Placebo	Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day	Baseline up to 3 months	Linear mixed effects regression will be utilized to analyze the longitudinal change of UPC between treatment and placebo groups.

Secondary Outcome Measures

Name	Time	Method
Improved glomerular filtration rate (GFR) >= 25%	Baseline up to 3 months	Linear mixed effects regression will be utilized to analyze the GFR between treatment and placebo groups.
Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg	Baseline up to 3 months	Linear mixed effects regression will be utilized to analyze the SBP between treatment and placebo groups.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States