Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 04/30/2019 |
| Prvo podneseno: | 08/21/2016 |
| Predviđena prijava poslana: | 08/23/2016 |
| Prvo objavljeno: | 08/28/2016 |
| Posljednje ažuriranje poslano: | 05/16/2019 |
| Posljednje ažuriranje objavljeno: | 05/20/2019 |
| Stvarni datum početka studija: | 10/22/2018 |
| Procijenjeni datum primarnog završetka: | 05/14/2019 |
| Procijenjeni datum završetka studije: | 05/14/2019 |
Stanje ili bolest
Intervencija / liječenje
Dietary Supplement: Group I (arginine)
Drug: Group II (placebo)
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Experimental: Group I (arginine) Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. | Dietary Supplement: Group I (arginine) Given PO |
| Placebo Comparator: Group II (placebo) Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. | Drug: Group II (placebo) Given PO |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | 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) |
Ishod
Primarne mjere ishoda
1. Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day [Baseline up to 3 months]
Sekundarne mjere ishoda
1. Improved glomerular filtration rate (GFR) >= 25% [Baseline up to 3 months]
2. Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg [Baseline up to 3 months]
