Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
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|ClinicalTrials.gov Identifier: NCT00390624|
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : June 3, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Dysfunction Acute Renal Failure Mortality||Drug: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE) Drug: MANNITOL||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|