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Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02882373
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location
2
Arms
6.7
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Arginine
  • Drug: Placebo
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
L-Arginine For Anti-VEGF Induced Kidney Injury
Actual Study Start Date :
Oct 23, 2018
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
May 15, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day [Baseline up to 3 months]

      Linear mixed effects regression will be utilized to analyze the longitudinal change of UPC between treatment and placebo groups.

    Secondary Outcome Measures

    1. Improved glomerular filtration rate (GFR) >= 25% [Baseline up to 3 months]

      Linear mixed effects regression will be utilized to analyze the GFR between treatment and placebo groups.

    2. Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg [Baseline up to 3 months]

      Linear mixed effects regression will be utilized to analyze the SBP between treatment and placebo groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Farhad Danesh, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02882373
    Other Study ID Numbers:
    • 2015-1105
    • NCI-2018-02537
    • 2015-1105
    • P30CA016672
    First Posted:
    Aug 29, 2016
    Last Update Posted:
    May 21, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Proteinuria

    Study Results

    No Results Posted as of May 21, 2019