Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.
- Age 18-65 years
- Presence of malignancy or hematological disease whose treatment will be allogeneic
stem cell transplant and high-dose conditioning therapy.
- Adequate baseline evaluation: adequate renal function (creatinine clearance > 60
ml/min); Adequate hepatic function (SGOT, SGPT, bilirubin and alkaline phosphatase <
1.5 times normal); adequate cardiac function (MUGA showing a left ventricular
ejection at rest > 45%); adequate pulmonary function (DCLO > 60%).
- Known hypersensitivity to ANP or mannitol
- Congestive heart failure
- Previous bone marrow transplant
- BP less than 90 mm systolic or less than 60 mm Hg diastolic
Type of Study:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
Chirag R Parikh, MD, PhD
Yale School of Medicine (Nephrology)
United States: Food and Drug Administration
- Renal Dysfunction
- Acute Renal Failure
- Acute Kidney Failure
- Acute Kidney Injury
- Renal Insufficiency
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