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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Renal Dysfunction, Acute Renal Failure, Mortality

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Renal function will be assessed for first 30 days after transplantation for the primary endpoint.

Principal Investigator

Chirag R Parikh, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale School of Medicine (Nephrology)

Authority:

United States: Food and Drug Administration

Study ID:

RMBMT-123

NCT ID:

NCT00390624

Start Date:

July 2003

Completion Date:

December 2006

Related Keywords:

  • Renal Dysfunction
  • Acute Renal Failure
  • Mortality
  • Urodilatin
  • Mannitol
  • Acute Kidney Failure
  • Acute Kidney Injury
  • Renal Insufficiency

Name

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