Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol - Full Text View

Purpose

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.

Condition	Intervention	Phase
Renal Dysfunction Acute Renal Failure Mortality	Drug: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE) Drug: MANNITOL	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation

Drug Information available for: Mannitol

U.S. FDA Resources

Further study details as provided by Rocky Mountain Cancer Centers:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	July 2003
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390624

Locations

United States, Colorado
Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200
Denver, Colorado, United States, 80218

Sponsors and Collaborators

Rocky Mountain Cancer Centers

University of Colorado, Denver

Investigators

Principal Investigator:

Chirag R Parikh, MD, PhD

Yale School of Medicine (Nephrology)

More Information

Publications:

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.

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00390624 History of Changes
Other Study ID Numbers:	RMBMT-123
Study First Received:	October 19, 2006
Last Updated:	May 30, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Rocky Mountain Cancer Centers:

Urodilatin
Mannitol
Acute Kidney Failure

Additional relevant MeSH terms:

Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mannitol
Atrial natriuretic factor prohormone (95-126)
Diuretics, Osmotic
Diuretics
Natriuretic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013