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Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Primary Purpose

Renal Dysfunction, Acute Renal Failure, Mortality

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)
MANNITOL
Sponsored by
Rocky Mountain Cancer Centers
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Dysfunction focused on measuring Urodilatin, Mannitol, Acute Kidney Failure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 19, 2006
Last Updated
May 30, 2008
Sponsor
Rocky Mountain Cancer Centers
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT00390624
Brief Title
Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
Official Title
Prevention Of Nephrotoxicity Following Allogeneic Bone Marrow Transplantation Using Urodilatin (Ularitide,Atrial Natriuretic Peptide) and Mannitol.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rocky Mountain Cancer Centers
Collaborators
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Dysfunction, Acute Renal Failure, Mortality
Keywords
Urodilatin, Mannitol, Acute Kidney Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)
Intervention Type
Drug
Intervention Name(s)
MANNITOL
Primary Outcome Measure Information:
Title
Renal function will be assessed for first 30 days after transplantation for the primary endpoint.
Title
The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival
Secondary Outcome Measure Information:
Title
Patient will be followed at 3 month intervals for the first year and then yearly for life.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chirag R Parikh, MD, PhD
Organizational Affiliation
Yale School of Medicine (Nephrology)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2645771
Citation
Zager RA, O'Quigley J, Zager BK, Alpers CE, Shulman HM, Gamelin LM, Stewart P, Thomas ED. Acute renal failure following bone marrow transplantation: a retrospective study of 272 patients. Am J Kidney Dis. 1989 Mar;13(3):210-6. doi: 10.1016/s0272-6386(89)80054-x.
Results Reference
background
PubMed Identifier
8546168
Citation
Gruss E, Bernis C, Tomas JF, Garcia-Canton C, Figuera A, Motellon JL, Paraiso V, Traver JA, Fernandez-Ranada JM. Acute renal failure in patients following bone marrow transplantation: prevalence, risk factors and outcome. Am J Nephrol. 1995;15(6):473-9. doi: 10.1159/000168889.
Results Reference
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PubMed Identifier
11961399
Citation
Letourneau I, Dorval M, Belanger R, Legare M, Fortier L, Leblanc M. Acute renal failure in bone marrow transplant patients admitted to the intensive care unit. Nephron. 2002 Apr;90(4):408-12. doi: 10.1159/000054728.
Results Reference
background
PubMed Identifier
8872980
Citation
Merouani A, Shpall EJ, Jones RB, Archer PG, Schrier RW. Renal function in high dose chemotherapy and autologous hematopoietic cell support treatment for breast cancer. Kidney Int. 1996 Sep;50(3):1026-31. doi: 10.1038/ki.1996.405.
Results Reference
background
PubMed Identifier
12110019
Citation
Parikh CR, McSweeney PA, Korular D, Ecder T, Merouani A, Taylor J, Slat-Vasquez V, Shpall EJ, Jones RB, Bearman SI, Schrier RW. Renal dysfunction in allogeneic hematopoietic cell transplantation. Kidney Int. 2002 Aug;62(2):566-73. doi: 10.1046/j.1523-1755.2002.00455.x.
Results Reference
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Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

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