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Completed

NCT Number: NCT00807794

A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection

To evaluate the clinical safety of different doses of MEDI-507 through day 33.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

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About this study

To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Renal allograft recipients receiving their first or second allograft
  • Age over 18
  • Maintained on conventional immunosuppression
  • Completed informed consent document

Exclusion criteria

  • Known hypersensitivity to MEDI-507
  • More than two renal allografts
  • Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial
  • Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert)
  • Any of the following clinical settings or diagnoses posttransplant:

pregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection

  • Having received OKT3, tacrolimus, or antilymphocyte globulin during the current allograft
  • Less than 10 ml/hr average urine output over 4 hours since the end of surgery

Treatment and study plan

MEDI-507

Drug

0.012 mg/kg dose given twice between 60 to 72 hours apart

Primary outcomes

  1. To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.

    Time frame: Day 33

Secondary outcomes

  1. To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.

    Time frame: Day 33

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection

Important dates

Study start
1997
Primary completion
1997
Study completion
1998
First posted
Dec 12, 2008
Registry last updated
Dec 12, 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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