Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01236378
• Date of registration: 05/11/2010
• Primary sponsor: Pfizer
• Public title: Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
• Scientific title: An Open-Label, Non-Randomized Study To Evaluate The Steady-State Pharmacokinetics Of Sirolimus Tablets In Chinese Patients With Stable Renal Allografts
• Date of first enrolment: December 2010
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01236378
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Transplantation

Transplant Rejection

Intervention(s)

Drug: Sirolimus

Primary Outcome(s)

Apparent Oral Clearance (CL/F) [Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose]

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State [Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose]

Average Blood Concentration at Steady State (Cave,ss) [Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose]

Degree of Fluctuation (DF) [Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose]

Maximum Observed Blood Concentration at Steady State (Cmax,ss) [Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose]

Observed Blood Trough Concentration at Steady State (Ctrough,ss) [Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose]

Time to Reach Maximum Observed Blood Concentration at Steady State (Tmax,ss) [Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose]

Secondary Outcome(s)

Number of Participants With Estimated Glomerular Filtration Rate (GFR) Less Than (<) 60 mL/Min/1.73 m^2 [Time Frame: From baseline up to Day 4]

Number of Participants With Serum Creatinine Levels More Than (>) 1.3 Times the Upper Limit of Normal [Time Frame: From baseline up to Day 4]

Secondary ID(s)

B1741018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors