N/A
Completed N=209
Study Investigating Rapamune For Post-Marketing Surveillance
Source: ClinicalTrials.gov NCT00484094 ↗Enrolled (actual)
209
Serious AEs
7.7%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs — 54.07; 43.06; 7.66; 2.87 Percentage of participants
Summary
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors in the Korean population, such as:
1. Unknown adverse reactions, especially serious adverse reactions
2. To assess the incidence of adverse reactions under the routine drug uses
3. Factors that may affect the safety of the drug (e.g., proteinuria)
4. Factors that may affect the effectiveness of the drug
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs |
54.07; 43.06; 7.66; 2.87; 2.39; 0.48 | — |
| PRIMARY Percentage of Participants With Clinically Significent Abnormal Laboratory Test |
— | — |
| SECONDARY Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies |
3.35 | — |
| SECONDARY Percentage of Participants Alive |
99.51 | — |
| SECONDARY Percentage of Participants With Survived Graft |
99.51 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula |
67.07 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects aged 13 years or older receiving renal transplants, who are newly administered Rapamune after a contract is made between Pfizer Korea and an investigator and/or an institution for conducting this study.
Exclusion Criteria
- Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients who have known hypersensitivity to Rapamune or its derivatives or any excipients in the formulation.
Data sourced from ClinicalTrials.gov (NCT00484094). 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.