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Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Chongqing, , 400038 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transplant Rejection, Renal Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female, above 18 years of age and Body Mass Index (BMI) of 18.0 to 25.0 kg/m2,
inclusive;

- Subjects must have received a primary or secondary renal allograft for at least 2
months prior to Screening;

- Subjects must be currently taking Rapamune tablets for prophylaxis of renal rejection.
The dosages of any medications must be stable for at least 2 weeks prior to screening
and continue with no change until completion of the last PK sample collection.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Acute rejection or vascular rejection episode in the 4 weeks prior to Screening; or
patients dependent on dialysis; or inadequate renal function (in the opinion of the
investigator);

- Recipients of multiple organ transplants (i.e., prior or concurrent transplantation of
any organs other than renal transplant);

- Current use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to
collection of the first PK sample and until collection of the final PK sample;

- Any clinically significant medical or psychiatric condition or laboratory abnormality,
in the judgment of the investigator.

NCT01236378
Pfizer
Completed
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients

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