NCT02882373

Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

L-Arginine For Anti-VEGF Induced Kidney Injury

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug-Induced Nephropathy
• Hypertension
• Proteinuria

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Arginine	Given PO
DRUG	Placebo	Given PO

Timeline

• Start date: 2018-10-23
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2016-08-29
• Last updated: 2019-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study