Kidney Transplantation
Conditions
Keywords
Rapamune, Safety, Efficacy, Kidney Transplantation
Brief 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
Detailed description
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Interventions
DRUGsirolimus
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. | All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely, were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. |
| Percentage of Participants With Clinically Significent Abnormal Laboratory Test | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. | Laboratory test was not mandatory because this study was a non-interventional study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed. |
| Percentage of Participants Alive | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | The investigator recorded the participant's survival status and evaluation date on the CRF. |
| Percentage of Participants With Survived Graft | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | Graft survival was defined as not showing graft loss at the time of evaluation. |
| Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF. |
Countries
South Korea
Participant flow
Recruitment details
Participants were enrolled between July 2011 and June 2015 from Korean health care centers.
Participants by arm
| Arm | Count |
|---|---|
| Rapamune Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. | 209 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued | 39 |
| Overall Study | Other | 3 |
Baseline characteristics
| Characteristic | Rapamune |
|---|---|
| Age, Continuous | 47.93 Years STANDARD_DEVIATION 13.1 |
| Gender Female | 81 Participants |
| Gender Male | 128 Participants |
| Type of Donation Cadaveric | 76 Participants |
| Type of Donation Living | 132 Participants |
| Type of Donation Unknown | 1 Participants |
| Type of Transplantation Primary Transplantation | 199 Participants |
| Type of Transplantation Secondary Transplantation | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 76 / 209 |
| serious Total, serious adverse events | 16 / 209 |
Outcome results
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
All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely, were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.
Time frame: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rapamune | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | AEs | 54.07 Percentage of participants |
| Rapamune | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | ADRs | 43.06 Percentage of participants |
| Rapamune | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | SAEs | 7.66 Percentage of participants |
| Rapamune | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | SADRs | 2.87 Percentage of participants |
| Rapamune | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | Unexpected SAEs | 2.39 Percentage of participants |
| Rapamune | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | Unexpected SADRs | 0.48 Percentage of participants |
Primary
Percentage of Participants With Clinically Significent Abnormal Laboratory Test
Laboratory test was not mandatory because this study was a non-interventional study.
Time frame: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
Population: This analysis was not performed because laboratory data were not collected during the study.
Secondary
Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula
Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.
Time frame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
Population: Efficacy Analysis Set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rapamune | Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula | 67.07 mL/min |
Secondary
Percentage of Participants Alive
The investigator recorded the participant's survival status and evaluation date on the CRF.
Time frame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
Population: Efficacy Analysis Set; Participants who had available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapamune | Percentage of Participants Alive | 99.51 Percentage of participants |
Secondary
Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies
Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.
Time frame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
Population: Efficacy Analysis Set: Participants with efficacy data recorded on the case report form (CRF) at 6 months (±1 month) after initiating Rapamune administration or at the time of completing Rapamune administration (whichever was earlier) were included in the Efficacy Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapamune | Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies | 3.35 Percentage of participants |
Secondary
Percentage of Participants With Survived Graft
Graft survival was defined as not showing graft loss at the time of evaluation.
Time frame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
Population: Efficacy Analysis Set; Participants who had available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapamune | Percentage of Participants With Survived Graft | 99.51 Percentage of participants |