Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
NCT ID: NCT00390624
Last Updated: 2008-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2003-07-31
2006-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
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URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)
MANNITOL
Eligibility Criteria
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Inclusion Criteria
* 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
* Congestive heart failure
* Previous bone marrow transplant
* BP less than 90 mm systolic or less than 60 mm Hg diastolic
18 Years
65 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Rocky Mountain Cancer Centers
OTHER
Principal Investigators
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Chirag R Parikh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale School of Medicine (Nephrology)
Locations
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Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200
Denver, Colorado, United States
Countries
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References
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Zager RA, O'Quigley J, Zager BK, Alpers CE, Shulman HM, Gamelin LM, Stewart P, Thomas ED. Acute renal failure following bone marrow transplantation: a retrospective study of 272 patients. Am J Kidney Dis. 1989 Mar;13(3):210-6. doi: 10.1016/s0272-6386(89)80054-x.
Gruss E, Bernis C, Tomas JF, Garcia-Canton C, Figuera A, Motellon JL, Paraiso V, Traver JA, Fernandez-Ranada JM. Acute renal failure in patients following bone marrow transplantation: prevalence, risk factors and outcome. Am J Nephrol. 1995;15(6):473-9. doi: 10.1159/000168889.
Letourneau I, Dorval M, Belanger R, Legare M, Fortier L, Leblanc M. Acute renal failure in bone marrow transplant patients admitted to the intensive care unit. Nephron. 2002 Apr;90(4):408-12. doi: 10.1159/000054728.
Merouani A, Shpall EJ, Jones RB, Archer PG, Schrier RW. Renal function in high dose chemotherapy and autologous hematopoietic cell support treatment for breast cancer. Kidney Int. 1996 Sep;50(3):1026-31. doi: 10.1038/ki.1996.405.
Parikh CR, McSweeney PA, Korular D, Ecder T, Merouani A, Taylor J, Slat-Vasquez V, Shpall EJ, Jones RB, Bearman SI, Schrier RW. Renal dysfunction in allogeneic hematopoietic cell transplantation. Kidney Int. 2002 Aug;62(2):566-73. doi: 10.1046/j.1523-1755.2002.00455.x.
Other Identifiers
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RMBMT-123
Identifier Type: -
Identifier Source: org_study_id