Status:
COMPLETED
Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
Lead Sponsor:
Rocky Mountain Cancer Centers
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Renal Dysfunction
Acute Renal Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00390624
Start Date
July 1 2003
End Date
December 1 2006
Last Update
June 3 2008
Active Locations (1)
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1
Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200
Denver, Colorado, United States, 80218