Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

NCT00390624 | Completed Phase 2 DMC

• 1 other identifier: RMBMT-123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dysfunction; Acute Renal Failure; Mortality

Keywords

Urodilatin; Mannitol; Acute Kidney Failure

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Patient will be followed at 3 month intervals for the first year and then yearly for life.

Interventions

URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE) DRUG

MANNITOL DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• Rocky Mountain Cancer Centers: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200

Denver, Colorado, 80218, United States

Location

Related Publications (5)

• 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.

  PMID: 2645771 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.

  PMID: 8546168 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.

  PMID: 11961399 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.

  PMID: 8872980 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.

  PMID: 12110019 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Acute Kidney Injury

Interventions

Ularitide; Atrial Natriuretic Factor; Mannitol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Chirag R Parikh, MD, PhD

  Yale School of Medicine (Nephrology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: July 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 3, 2008

Record last verified: 2008-05

Locations

US (1)