Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by:
Rocky Mountain Cancer Centers
ClinicalTrials.gov Identifier:
NCT00390624
First received: October 19, 2006
Last updated: May 30, 2008
Last verified: May 2008
  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:


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
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, see Learn About Clinical Studies.

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:
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:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Mannitol
Ularitide
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 September 18, 2014