Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

M.D. Anderson Cancer Center

Status and phase: Withdrawn; Phase 2

Conditions: Hypertension; Proteinuria; Drug-Induced Nephropathy

Treatments: Drug: Placebo; Dietary Supplement: Arginine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02882373

P30CA016672 (U.S. NIH Grant/Contract)

NCI-2018-02537 (Registry Identifier)

2015-1105 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Group I (arginine)

Experimental group

Description:

Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.

Treatment:

Dietary Supplement: Arginine

Group II (placebo)

Placebo Comparator group

Description:

Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.

Treatment:

Drug: Placebo