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Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

Primary Purpose

Drug-Induced Nephropathy, Hypertension, Proteinuria

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Arginine
Placebo
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug-Induced Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group I (arginine)

Group II (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improved glomerular filtration rate (GFR) >= 25%
Linear mixed effects regression will be utilized to analyze the GFR between treatment and placebo groups.
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.

Full Information

First Posted
August 22, 2016
Last Updated
May 17, 2019
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02882373
Brief Title
Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury
Official Title
L-Arginine For Anti-VEGF Induced Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator's Request
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Induced Nephropathy, Hypertension, Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (arginine)
Arm Type
Experimental
Arm Description
Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
Arm Title
Group II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Arginine
Other Intervention Name(s)
Amino-5-guanidino-pentanoic acid, Arg, L-Arginine
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day
Description
Linear mixed effects regression will be utilized to analyze the longitudinal change of UPC between treatment and placebo groups.
Time Frame
Baseline up to 3 months
Secondary Outcome Measure Information:
Title
Improved glomerular filtration rate (GFR) >= 25%
Description
Linear mixed effects regression will be utilized to analyze the GFR between treatment and placebo groups.
Time Frame
Baseline up to 3 months
Title
Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg
Description
Linear mixed effects regression will be utilized to analyze the SBP between treatment and placebo groups.
Time Frame
Baseline up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhad Danesh
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

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