Kidney TransplantationNCT00484094
Study Investigating Rapamune For Post-Marketing Surveillance
An observational study of Kidney Transplantation, run by Pfizer at 11 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- sirolimus
- How many people
- 209 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Jul 2011to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who receive Rapamune after kidney transplantation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Yeungnam University Medical Center
Daegu, 705-717
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Gyeonggi-do, 480-717
Maryknoll Medical Center
Pusan, 600-730
Seoul National University Hospital (SNUH)
Seoul, Seoul, 110-744
Kangdong Sacred Heart Hospital
Seoul, 134-814
Samsung Medical Center
Seoul, 135-710
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 135-720
Korea University Anam Hospital
Seoul, 136-705
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
Konkuk University Medical Center
Seoul, 143-729
About this study
Official title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
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:
- Unknown adverse reactions, especially serious adverse reactions
- To assess the incidence of adverse reactions under the routine drug uses
- Factors that may affect the safety of the drug (e.g., proteinuria)
- Factors that may affect the effectiveness of the drug
Read the detailed description
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
- Conditions
- Kidney Transplantation
- Being tested
- sirolimus
- Keywords
- Rapamune, Safety, Efficacy, Kidney Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
Also called Rapamune
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
| Study group | Role | What they receive |
|---|---|---|
| Rapamune | Not described Receives: Drug: sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484094
- Sponsor's protocol ID
- 0468X1-4411
- Other IDs
- B1741015
- Status last verified
- Nov 2016
- First submitted
- 7 Jun 2007
- Last updated
- 16 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
- ClinicalTrials.gov ID
- NCT00484094
- Acronym / sponsor ID
- 0468X1-4411
- Conditions
- Kidney Transplantation
- Keywords
- Rapamune, Safety, Efficacy, Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Posted 16 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Unknown adverse reactions, especially serious adverse reactions
- To assess the incidence of adverse reactions under the routine drug uses
- Factors that may affect the safety of the drug (e.g., proteinuria)
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapamune | – | Drug: sirolimus |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who receive Rapamune after kidney transplantation
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sirolimusAlso: RapamuneDosage and treatment duration will be decided by physician's discretion considering patient's clinical situations | Drug | Rapamune |
Primary outcome
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
Time frame: 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
Time frame: 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.
4 secondary outcomes
Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Pfizer at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs (time frame: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.