Drug-Induced Nephropathy, Hypertension, Proteinuria
Conditions
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.
Interventions
DIETARY_SUPPLEMENTArginine
Given PO
DRUGPlacebo
Given PO
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed