Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

L-Arginine For Anti-VEGF Induced Kidney Injury

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Proteinuria; Drug-Induced Nephropathy
• Intervention / Treatment: Drug: Placebo; Dietary supplement: Arginine

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (arginine); Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.	Dietary supplement: Arginine; Given PO; Other Names: Amino-5-guanidino-pentanoic acid; Arg; L-Arginine
Placebo Comparator: Group II (placebo); Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.	Drug: Placebo; Given PO; Other Names: placebo therapy; PLCB; sham therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Farhad Danesh, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria
• Other Study ID Numbers: 2015-1105 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2018-02537 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No