Kidney Cancer Clinical Trial

Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT00390624

Recruitment Status:

Completed

Sponsor:

Rocky Mountain Cancer Centers

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT00390624

Recruitment Status:

Completed

Sponsor:


Rocky Mountain Cancer Centers

How clear is this clinincal trial information?

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