Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
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.
|Renal Dysfunction Acute Renal Failure Mortality||Drug: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE) Drug: MANNITOL||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.|
- Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
- The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival
- Patient will be followed at 3 month intervals for the first year and then yearly for life.
|Study Start Date:||July 2003|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390624
|United States, Colorado|
|Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200|
|Denver, Colorado, United States, 80218|
|Principal Investigator:||Chirag R Parikh, MD, PhD||Yale School of Medicine (Nephrology)|