Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Phase 2

Completed

• Conditions: Renal Dysfunction; Acute Renal Failure; Mortality

• Registration Number: NCT00390624
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-19
• Study First Posted: 2006-10-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-30
• Last Update Posted: 2008-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200; 🇺🇸 Denver, Colorado, United States