Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

Hypertension Clinical Trial

Official title:

L-Arginine For Anti-VEGF Induced Kidney Injury

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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
• 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
• 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• Status: Withdrawn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)

Related Conditions & MeSH terms

• Drug-Induced Nephropathy
• Hypertension
• Proteinuria

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