Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease, Endocrine, Nephrology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | October 23, 2018 |
| End Date: | October 31, 2020 |
| Contact: | Farhad Danesh |
| Email: | fdanesh@mdanderson.org |
| Phone: | 713-745-8597 |
L-Arginine For Anti-VEGF Induced Kidney Injury
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.
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.
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.
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.
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)
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Farhad Danesh
Phone: 713-745-8597
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