Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390624

Enrollment

Registered

2006-10-20

Start date

2003-07-31

Completion date

2006-12-31

Last updated

2008-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Mortality, Renal Dysfunction

Keywords

Urodilatin, Mannitol, Acute Kidney Failure

Brief 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.

Interventions

DRUGURODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)

DRUGMANNITOL

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

* 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

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026