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Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients

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NCT01236378

Last updated on November 7, 2019
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Study Location
Pfizer Investigational Site
Chongqing, , 400038 China
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Official Title  ICMJE An Open-Label, Non-Randomized Study To Evaluate The Steady-State Pharmacokinetics Of Sirolimus Tablets In Chinese Patients With Stable Renal Allografts
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 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

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Transplant Rejection
  • Renal Transplantation
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications *Wang HF, Qiu F, Wu X, Fang J, Crownover P, Korth-Bradley J, Schulman S. Steady-state pharmacokinetics of sirolimus in stable adult Chinese renal transplant patients. Clin Pharmacol Drug Dev. 2014 May;3(3):235-41. doi: 10.1002/cpdd.96. Epub 2014 Feb 10.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2011)		24
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2010)		12
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion DateApril 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01236378
Other Study ID Numbers  ICMJE B1741018
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2011

ICMJE     Data element required by the

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

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