Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Dysfunction, Acute Renal Failure, Mortality

Intervention / Treatment
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* Drug: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)
* Drug: MANNITOL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)|nan|
|Drug: MANNITOL|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Patient will be followed at 3 month intervals for the first year and then yearly for life. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urodilatin, Mannitol, Acute Kidney Failure