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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02537 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-1105 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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Principal Investigator's Request
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (arginine) | Experimental | Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. |
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| Group II (placebo) | Placebo Comparator | Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arginine | Dietary Supplement | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farhad Danesh | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Placebo | Drug | Given PO |
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Linear mixed effects regression will be utilized to analyze the SBP between treatment and placebo groups. |
| Baseline up to 3 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000601 | Amino Acids, Essential |