Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
Information source: Rocky Mountain Cancer Centers
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Dysfunction; Acute Renal Failure; Mortality
Intervention: URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE) (Drug); MANNITOL (Drug)
Phase: Phase 2
Sponsored by: Rocky Mountain Cancer Centers
Official(s) and/or principal investigator(s):
Chirag R Parikh, MD, PhD, Principal Investigator, Affiliation: Yale School of Medicine (Nephrology)
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: Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.
Study design: Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment
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: Patient will be followed at 3 month intervals for the first year and then yearly for life.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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%).
- 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
Locations and Contacts
Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200, Denver, Colorado 80218, United States
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Starting date: July 2003
Ending date: December 2006
Last updated: May 30, 2008