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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE) | Drug | |||
| MANNITOL | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient will be followed at 3 month intervals for the first year and then yearly for life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chirag R Parikh, MD, PhD | Yale School of Medicine (Nephrology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200 | Denver | Colorado | 80218 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2645771 | Background | 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. | |
| 8546168 | Background | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C056452 | Ularitide |
| D009320 | Atrial Natriuretic Factor |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| 11961399 | Background | 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. |
| 8872980 | Background | 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. |
| 12110019 | Background | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |