Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Mortality Clinical Trial

Official title:

Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390624
• Other study ID #: RMBMT-123
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2006
• Last updated: May 30, 2008
• Start date: July 2003
• Est. completion date: December 2006

Study information

• Verified date: May 2008
• Source: Rocky Mountain Cancer Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Mortality
• Renal Dysfunction
• Renal Insufficiency

Intervention

Drug:
• URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)

• MANNITOL

Locations

Country	Name	City	State
United States	Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Rocky Mountain Cancer Centers	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gruss E, Bernis C, Tomas JF, Garcia-Canton C, Figuera A, Motellón JL, Paraiso V, Traver JA, Fernandez-Rañada JM. Acute renal failure in patients following bone marrow transplantation: prevalence, risk factors and outcome. Am J Nephrol. 1995;15(6):473-9. — View Citation

Létourneau I, Dorval M, Bélanger R, Légaré 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
Primary	The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival
Secondary	Patient will be followed at 3 month intervals for the first year and then yearly for life.