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Prevention of Nephrotocity Following Allogeneic Bone Marrow Transplantation using Urodilatin (Ularitide, Atrial Natriuretic Peptide) and Mannitol
Principal Investigator: Peter A. McSweeney, MD
Protocol Number: RMBMT-123
Major Objectives
The aim of this study is to evaluate the protective effect of combined Urodilatin and mannitol on the development of renal dysfunction, ARF and mortality in allogeneic transplant patients receiving either bone marrow or peripheral blood progenitor cells. Specifically, the study will compare renal function, requirement for dialysis and mortality in 20 consecutive allogeneic bone marrow transplant patients with historical controls.
Thus the primary end points are:
- Grade of renal dysfunction
- Dialysis requirement
- Overall Survival
This is a phase II study investigating the protective effect of Urodilatin and mannitol on the grade of renal dysfunction, incidence of ARF requiring dialysis and mortality in allogeneic bone marrow transplantation. The study will consist of 20 patients. Patients will be given an infusion of Urodilatin and Mannitol beginning two days before the transplant and continued for a total of 14 days.
Patient Selection
Inclusion Criteria:
- 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%).
Exclusion Criteria:
- 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
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