Planned Kidney TransplantationPhase 4NCT01706471
Safety and Efficacy of the Early Introduction of Everolimus (Certican®) With Low Dose of Cyclosporine in de Novo Kidney Recipients After 1 Month of Transplantation
A Phase 4 study testing Everolimus + Low dose CsA +PD and Myfortic+ Standard CsA + PD in people with Planned Kidney Transplantation, run by Yonsei University at 1 site in South Korea.
Trial summary
Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection episodes of cadaveric allograft recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Planned Kidney Transplantation
- What is being tested?
- Everolimus + Low dose CsA +PD and Myfortic+ Standard CsA + PD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or Females aged 18~65 years
- De novo recipients of cadaveric, living unrelated or living related donor kidney transplants
- Received kidney transplant from aged 10~65years donor
- Willing to provide written informed consent
- Completing study visits according to study protocol
Who cannot join
- Recipients of multiple organ transplants
- Kidney transplant from non-heart beating cadaveric donor / organ donor after cardiac death
- Recipients of A-B-O incompatible transplants or lymphocyte cross-match positive transplants
- Recipients of extra-renal solid organ transplants or stem cell transplants
- Recipient/ donor who are known to have anti-HCV, HIV or HBsAg positive
- Diagnosed as Cancer within the past 5 years (except complete recovered squamous cell or basal cell skin cancer)
Show all 11Show fewer
- Drug Hypersensitivity to investigational drugs or related drugs Females are pregnant and lactating
- Any of the following laboratory abnormalities at screening:
- ALT, AST, ALP, total bilirubin > 3 times the upper limit
- ANC < 1,500mm3 or WBC < 2,500mm3 or platelet < 100,000 mm3
- Cholesterol > 350 mg/dl or 9.0 mmol/L, TG > 500 mg/dl or 5.6mmol/L
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Yonsei University College of Medicine, Severance Hospital
Seoul, Seoul, 120-752
About this study
Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection episodes of cadaveric allograft recipients. Although marked progression has been made in initial survival rates, long-term kidney graft survival has yet to show such encouraging results. Because CNIs are associated with adverse effects, particularly nephrotoxicity, which contribute to declining organ function and eventual graft loss. In kidney transplants, progressive allograft dysfunction has been shown to develop in as many as 94% of patients by 1 year.
Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be balanced against the maintenance of adequate immunosuppression.
Read more
Certican allows CNI dose reduction then provides renal function improvement and current PSI strategy point out that early intervention is important in managing the risk of CAN before it develops in both de novo and maintenance renal transplant recipients.
To demonstrate Certican early introduction after 1 month provides better renal function with no change of efficacy compared to standard regimen, and also prevent delayed wound healing.
- Conditions
- Planned Kidney Transplantation
- Being tested
- Everolimus + Low dose CsA +PD, Myfortic+ Standard CsA + PD
- Keywords
- verLowCNI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus + Low dose CsA +PDDrug
Group A : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng. After 1 month reduce Neoral dose as following table and Certican starting 0.75mg bid then adjust Certican 3-8ng/ml. Myfortic continue until Certican trough level goes up >3 ng/mL. Steroid dose follows local protocol.
Myfortic+ Standard CsA + PDDrug
Group B : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng/ml. After 1 month reduce Neoral dose targeting 100-200ng with no change of Myfortic dose. Steroid dose follows local protocol.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus + Low dose CsA +PD | Experimental | Not described Receives: Drug: Everolimus + Low dose CsA +PD |
| Myfortic+ Standard CsA + PD | Active comparator | Not described Receives: Drug: Myfortic+ Standard CsA + PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Exposure Cyclosporine in Renal Transplant Recipients
A 12-month, multi center, randomized, open-label, non-inferiority study of efficacy and safety comparing early introduction of Certican® after 1 month and standard regimen in de novo renal transplant recipients
Measured: 12 months after the time of kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startJun 2009
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Planned Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706471
- Sponsor's protocol ID
- 4-2009-0109
- Status last verified
- Feb 2014
- First submitted
- 8 Oct 2012
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oh CK, Huh KH, Ha J, Kim YH, Kim YL, Kim YS. Safety and efficacy of the early introduction of everolimus with reduced-exposure cyclosporine a in de novo kidney recipients. Transplantation. 2015 Jan;99(1):180-6. doi: 10.1097/TP.0000000000000225.
PubMed 24983307
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Early Introduction of Everolimus (Certican®) With Low Dose of Cyclosporine in de Novo Kidney Recipients After 1 Month of Transplantation
- ClinicalTrials.gov ID
- NCT01706471
- Acronym / sponsor ID
- 4-2009-0109
- Conditions
- Planned Kidney Transplantation
- Keywords
- verLowCNI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection episodes of cadaveric allograft recipients. Although marked progression has been made in initial survival rates, long-term kidney graft survival has yet to show such encouraging results. Because CNIs are associated with adverse effects, particularly nephrotoxicity, which contribute to declining organ function and eventual graft loss. In kidney transplants, progressive allograft dysfunction has been shown to develop in as many as 94% of patients by 1 year.
Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be balanced against the maintenance of adequate immunosuppression.
Certican allows CNI dose reduction then provides renal function improvement and current PSI strategy point out that early intervention is important in managing the risk of CAN before it develops in both de novo and maintenance renal transplant recipients.
To demonstrate Certican early introduction after 1 month provides better renal function with no change of efficacy compared to standard regimen, and also prevent delayed wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus + Low dose CsA +PD | Experimental | Drug: Everolimus + Low dose CsA +PD |
| Myfortic+ Standard CsA + PD | Active comparator | Drug: Myfortic+ Standard CsA + PD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or Females aged 18~65 years
- De novo recipients of cadaveric, living unrelated or living related donor kidney transplants
- Received kidney transplant from aged 10~65years donor
- Willing to provide written informed consent
- Completing study visits according to study protocol
Key exclusion criteria (11 listed)
- Recipients of multiple organ transplants
- Kidney transplant from non-heart beating cadaveric donor / organ donor after cardiac death
- Recipients of A-B-O incompatible transplants or lymphocyte cross-match positive transplants
- Recipients of extra-renal solid organ transplants or stem cell transplants
- Recipient/ donor who are known to have anti-HCV, HIV or HBsAg positive
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 |
|---|---|---|
| Everolimus + Low dose CsA +PDGroup A : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng. After 1 month reduce Neoral dose as following table and Certican starting 0.75mg bid then adjust Certican 3-8ng/ml. Myfortic continue until Certican trough level goes up >3 ng/mL. Steroid dose follows local protocol. | Drug | Everolimus + Low dose CsA +PD |
| Myfortic+ Standard CsA + PDGroup B : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng/ml. After 1 month reduce Neoral dose targeting 100-200ng with no change of Myfortic dose. Steroid dose follows local protocol. | Drug | Myfortic+ Standard CsA + PD |
Primary outcome
Reduced Exposure Cyclosporine in Renal Transplant Recipients
Time frame: 12 months after the time of kidney transplantation
A 12-month, multi center, randomized, open-label, non-inferiority study of efficacy and safety comparing early introduction of Certican® after 1 month and standard regimen in de novo renal transplant recipients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Derived from this study: PubMed 24983307Oh CK, Huh KH, Ha J, Kim YH, Kim YL, Kim YS. Safety and efficacy of the early introduction of everolimus with reduced-exposure cyclosporine a in de novo kidney recipients. Transplantation. 2015 Jan;99(1):180-6. doi: 10.1097/TP.0000000000000225.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus + Low dose CsA +PD and Myfortic+ Standard CsA + PD in people with Planned Kidney Transplantation, run by Yonsei University at 1 site 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 5 inclusion and 11 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduced Exposure Cyclosporine in Renal Transplant Recipients (time frame: 12 months after the time of kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01706471, which also lists 1 linked publication.
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 19 Feb 2014.