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| ID | Type | Description | Link |
|---|---|---|---|
| B1741015 | Other Identifier | Alias Study Number |
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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:
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapamune |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus | Drug | Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. |
| Percentage of Participants With Clinically Significent Abnormal Laboratory Test | Laboratory test was not mandatory because this study was a non-interventional study. | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who receive Rapamune after kidney transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital (SNUH) | Seoul | Seoul | 110-744 | South Korea | ||
| Yeungnam University Medical Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants were enrolled between July 2011 and June 2015 from Korean health care centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: Participants who received Rapamune at least once and were evaluated on its related safety endpoints at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Analysis Set | Posted | Number | Percentage of participants | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. |
|
Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
| Percentage of Participants Alive | The investigator recorded the participant's survival status and evaluation date on the CRF. | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
| Percentage of Participants With Survived Graft | Graft survival was defined as not showing graft loss at the time of evaluation. | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
| 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. | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
| Daegu |
| 705-717 |
| South Korea |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital | Gyeonggi-do | 480-717 | South Korea |
| Maryknoll Medical Center | Pusan | 600-730 | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | 134-814 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 135-720 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Konkuk University Medical Center | Seoul | 143-729 | South Korea |
| Years |
|
| Gender | Count of Participants | Participants |
|
| Type of Transplantation | Primary transplantation: Participants received renal transplantation for the first time. Secondary transplantation: Participants received renal re-transplantation. | Number | Participants |
|
| Type of Donation | Number | Participants |
|
|
|
| Primary | Percentage of Participants With Clinically Significent Abnormal Laboratory Test | Laboratory test was not mandatory because this study was a non-interventional study. | This analysis was not performed because laboratory data were not collected during the study. | Posted | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. |
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
|
|
|
| Secondary | Percentage of Participants Alive | The investigator recorded the participant's survival status and evaluation date on the CRF. | Efficacy Analysis Set; Participants who had available data. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
|
|
|
| Secondary | Percentage of Participants With Survived Graft | Graft survival was defined as not showing graft loss at the time of evaluation. | Efficacy Analysis Set; Participants who had available data. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
|
|
|
| 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. | Efficacy Analysis Set. | Posted | Median | Full Range | mL/min | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. |
|
|
|
| 16 |
| 209 |
| 76 |
| 209 |
| Hypertension | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
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| Plasma osmolality increased | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Angina pectoris aggravated | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
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| Azotaemia | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
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| Urinary tract disorder | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Polyomavirus infection | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
|
| Cystitis | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Infection susceptibility increased | General disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Stomatitis ulcerative | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
|
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