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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02882373
Other study ID # 2015-1105
Secondary ID NCI-2018-0253720
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date October 23, 2018
Est. completion date May 15, 2019

Study information

Verified date May 2019
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 15, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Arginine
Given PO
Drug:
Placebo
Given PO

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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