Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Rocky Mountain Cancer Centers

Status and phase

Completed

Phase 2

Conditions

Mortality

Acute Renal Failure

Renal Dysfunction

Treatments

Drug: MANNITOL

Drug: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)

Study type

Interventional

Funder types

Other

Identifiers

NCT00390624

RMBMT-123

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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