Phase 1
Completed N=24
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Transplant Rejection · Renal Transplantation
Source: ClinicalTrials.gov NCT01236378 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Maximum Observed Blood Concentration at Steady State (Cmax,ss) — 14.07 nanogram per milliliter (ng/mL)
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Blood Concentration at Steady State (Cmax,ss) |
14.07 | — |
| PRIMARY Time to Reach Maximum Observed Blood Concentration at Steady State (Tmax,ss) |
2.49 | — |
| PRIMARY Observed Blood Trough Concentration at Steady State (Ctrough,ss) |
5.906 | — |
| PRIMARY Average Blood Concentration at Steady State (Cave,ss) |
8.297 | — |
| PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State |
199.3 | — |
| PRIMARY Degree of Fluctuation (DF) |
1.064 | — |
| PRIMARY Apparent Oral Clearance (CL/F) |
10.14 | — |
| SECONDARY Number of Participants With Serum Creatinine Levels More Than (>) 1.3 Times the Upper Limit of Normal |
5; 4 | — |
| SECONDARY Number of Participants With Estimated Glomerular Filtration Rate (GFR) Less Than (<) 60 mL/Min/1.73 m^2 |
7; 7 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01236378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.