Clinical trial NCT00390624: Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
Official title: Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Dysfunction
Acute Renal Failure
Mortality
Keywords: Urodilatin
Mannitol
Acute Kidney Failure
Lead sponsor: Rocky Mountain Cancer Centers
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2006-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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. 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
measure: The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival
Secondary outcomes:
measure: Patient will be followed at 3 month intervals for the first year and then yearly for life.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200
state: Colorado
Study officials:
affiliation: Yale School of Medicine (Nephrology)
name: Chirag R Parikh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.