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Completed

NCT Number: NCT00390624

Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

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.

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Key information

Conditions

Renal Dysfunction Acute Kidney Injury Acute Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mortality Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200

Denver, Colorado, 80218, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)

Drug

Mannitol

Drug

Primary outcomes

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

  2. The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Rocky Mountain Cancer Centers

Other

Collaborators

  • University of Colorado, Denver

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Oct 20, 2006
Registry last updated
Jun 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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