Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

May 30, 2008 updated by: Rocky Mountain Cancer Centers

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rocky Mountain Cancer Centers

Collaborators

University of Colorado, Denver

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 20, 2006

Study Record Updates

Last Update Posted (Estimate)

June 3, 2008

Last Update Submitted That Met QC Criteria

May 30, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMBMT-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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