Trial | NCT00390624  Report issue

Title

Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mannitol urodilatin ...

  • Study Participants

    20
The purpose of the study is to combine Urodilatin (ANP analogue), which will increase glomerular filtration rate (GFR), and mannitol, which will increase the rate of urinary flow and solute excretion. We intend to treat twenty consecutive allogeneic bone marrow transplant patients in a phase II study comparing results with historical controls.

We hypothesize that the incidence of renal dysfunction, ARF and thus mortality in allogeneic bone marrow transplantation can be significantly reduced by the use of protective agents Urodilatin and mannitol. We feel that this combination is best administered prior to and during the first two weeks of treatment when patients encounter immunosuppressive agents and the onset of early transplantation complications.
Study Started
Jul 31
2003
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Jun 03
2008
Estimate

Drug URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)

Drug MANNITOL

Criteria 

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
No Results Posted