Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

NCT02882373 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: 2015-1105NCI-2018-02537P30CA016672
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-Induced Nephropathy; Hypertension; Proteinuria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improved glomerular filtration rate (GFR) >= 25%

  Baseline up to 3 months

• Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg

  Baseline up to 3 months

Study Arms (2)

Group I (arginine)

EXPERIMENTAL

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

Dietary Supplement: Arginine

Group II (placebo)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Arginine DIETARY_SUPPLEMENT

Given PO

Also known as: Amino-5-guanidino-pentanoic acid, Arg, L-Arginine

Group I (arginine)

Placebo DRUG

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Group II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension; Proteinuria

Interventions

Arginine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Farhad Danesh

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 29, 2016
• Study Start: October 23, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (1)