Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2019-05-15

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.

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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.

Conditions

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Drug-Induced Nephropathy Hypertension Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I (arginine)

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

Group Type EXPERIMENTAL

Arginine

Intervention Type DIETARY_SUPPLEMENT

Given PO

Group II (placebo)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Given PO

Interventions

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Arginine

Given PO

Intervention Type DIETARY_SUPPLEMENT

Placebo

Given PO

Intervention Type DRUG

Other Intervention Names

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Amino-5-guanidino-pentanoic acid Arg L-Arginine placebo therapy PLCB sham therapy

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No