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Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients

Last updated on October 4, 2018

FOR MORE INFORMATION
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.
Show details

- 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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Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
An Open-Label, Non-Randomized Study To Evaluate The Steady-State Pharmacokinetics Of Sirolimus Tablets In Chinese Patients With Stable Renal Allografts

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 in renal allograft recipients was requested by State Food and Drug Administration (SFDA) to provide further guidance for clinical use.

To minimize risk to patients, this study is designed to collect blood PK samples from renal allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or without concomitant medication(s). PK samples will be collected from these patients to characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This study will not involve any changes to the established treatment regimen for the patients who enroll in the study

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Transplant Rejection
  • Renal Transplantation
Drug: Sirolimus
Sirolimus, 1 mg, white, triangular tablets, daily dose, dosages of any of these 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.
Other Name: Rapamune
Experimental: sirolimus
Subjects must be taking sirolimus (1 mg tablet formulation) with or without concomitant medications, unless specifically excluded below, for prophylaxis of renal rejection.
Intervention: Drug: Sirolimus
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2011
April 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01236378
B1741018
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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