Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Rocky Mountain Cancer Centers20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Dysfunction Acute Renal Failure Mortality

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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