Status:
COMPLETED
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Lead Sponsor:
Pfizer
Conditions:
Transplant Rejection
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to be conducted ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01236378
Start Date
December 1 2010
End Date
April 1 2011
Last Update
March 1 2012
Active Locations (2)
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1
Pfizer Investigational Site
Chongqing, China, 400038
2
Pfizer Investigational Site
Shanghai, China, 200127