Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390624
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : June 3, 2008
University of Colorado, Denver
Information provided by:
Rocky Mountain Cancer Centers

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.
Study Start Date : July 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

Primary Outcome Measures :
  1. Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
  2. The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival

Secondary Outcome Measures :
  1. Patient will be followed at 3 month intervals for the first year and then yearly for life.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390624

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
Principal Investigator: Chirag R Parikh, MD, PhD Yale School of Medicine (Nephrology)

Publications: Identifier: NCT00390624     History of Changes
Other Study ID Numbers: RMBMT-123
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: May 2008

Keywords provided by Rocky Mountain Cancer Centers:
Acute Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents