Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246129
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2005-10-28
Brief Title:
CamTac TrialCampath-Tacrolimus vs IL2R MoAbTacrolimusMMF in Renal Transplantation
Sponsor:
EMagnusson
Organization:
Imperial College Healthcare NHS Trust
Study Overview
Official Title:
A Randomised Controlled Comparison of Campath-Tacrolimus vs IL2R MoAb-TacrolimusMycophenolate Mofetil in Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The advent of new potent immunosuppressive anti-rejection drugs over the past ten years has substantially reduced the risk of rejection after kidney transplantation has allowed the development of immuno-suppressive regimens that do not use long-term steroids steroid avoidance and has improved transplant success rates both in the short and medium term
The main new agents used in these modern regimens are the calcineurin inhibitor CNI tacrolimus the anti-proliferative agent mycophenolate and induction agents which are used to provide effective early suppression of the rejection process these include monoclonal antibodies MoAb such as IL-2 receptor blocking antibodies IL-2R MoAb basiliximab and daclizumab and the anti-CD52 antibody Campath-1H alemtuzumab
Although almost all modern immunosuppressive regimens involve one or more of these agents it is not known which is the safest and most effective combination
This randomised controlled trial compares two steroid sparing regimens which have been used with very good short and medium term results at St Marys Hospital Renal and Transplant Unit over the last 5 years The primary hypothesis is that the alemtuzumabtacrolimus regimen is as effective and safe as the IL-2R MoAbtacrolimusmycophenolate regimen
The main new agents used in these modern regimens are the calcineurin inhibitor CNI tacrolimus the anti-proliferative agent mycophenolate and induction agents which are used to provide effective early suppression of the rejection process these include monoclonal antibodies MoAb such as IL-2 receptor blocking antibodies IL-2R MoAb basiliximab and daclizumab and the anti-CD52 antibody Campath-1H alemtuzumab
Although almost all modern immunosuppressive regimens involve one or more of these agents it is not known which is the safest and most effective combination
This randomised controlled trial compares two steroid sparing regimens which have been used with very good short and medium term results at St Marys Hospital Renal and Transplant Unit over the last 5 years The primary hypothesis is that the alemtuzumabtacrolimus regimen is as effective and safe as the IL-2R MoAbtacrolimusmycophenolate regimen
Detailed Description:
RECENT EXPERIENCE AT ST MARYS
The St Marys Hospital Renal Unit now combined with the Hammersmith Hospital Renal Unit at the West London Renal and Transplant Centre introduced Tacrolimus based immunosuppression in 1995 developing a steroid avoidance regimen based on Tacrolimus Mycophenolate and IL-2R MoAb between 2000 and 2002 and moving to Campath-1H as an induction agent in 2004 Results over this period have been excellent with five and ten year survivals with functioning graft rates of 82 and 72 for the first 260 cadaveric kidney transplants performed since 1995
The two most recent regimens used at St Marys have both produced very low 10 rejection rates and very good 90 short-term rejection-free patient and graft survival rates Between 2002 and 2004 the regimen consisted of induction with an Interleukin-2 IL2 -Receptor blocking monoclonal antibody with Tacrolimus and Mycophenolate as long term maintenance therapy In patients without rejection steroid usage was limited to the first 7 days post-transplant The current regimen uses Campath-1H which is now well established as an induction agent in renal transplantation for induction with Tacrolimus monotherapy maintenance and an identical short-course steroid regimen
CHARACTERISTICS OF THE TWO REGIMENS TO BE COMPARED
The IL2R MoAbTacrolimusMycophenolateShort-course steroids regimen 2002-2004 Regimen 1 has the advantage of flexibility in terms of adjusting maintenance therapy to allow clinical response to patients and transplants with different tolerance of the two maintenance agents but involves increased expense in terms of using and monitoring the blood levels of two modern and hence expensive agents In addition patients have long-term exposure to the anti-proliferative agent Mycophenolate which can be associated with increased risk of infection gastrointestinal side effects and skin malignancies
The Campath-1HTacrolimusShort-course steroids regimen 2004-current Regimen 2 has the advantage of highly effective immunosuppression in the initial 3-month period allowing lower doses of the potentially nephrotoxic Tacrolimus to be used and simplicity but exposes patients to a period of several months of lymphopenia reduced lymphocyte counts in the blood after Campath administration and reliance on Tacrolimus monotherapy for maintenance which might lead to greater long term Tacrolimus exposure
PROPOSED STUDY
In order to allow a proper comparison of these two anti-rejection treatment combinations we propose a randomised trial which will enable us to consider the relative merits of the two regimens without the introduction of bias associated with using historical control groups Transplant recipients will be randomised in a 12 ratio to regimen 1 and regimen 2
The St Marys Hospital Renal Unit now combined with the Hammersmith Hospital Renal Unit at the West London Renal and Transplant Centre introduced Tacrolimus based immunosuppression in 1995 developing a steroid avoidance regimen based on Tacrolimus Mycophenolate and IL-2R MoAb between 2000 and 2002 and moving to Campath-1H as an induction agent in 2004 Results over this period have been excellent with five and ten year survivals with functioning graft rates of 82 and 72 for the first 260 cadaveric kidney transplants performed since 1995
The two most recent regimens used at St Marys have both produced very low 10 rejection rates and very good 90 short-term rejection-free patient and graft survival rates Between 2002 and 2004 the regimen consisted of induction with an Interleukin-2 IL2 -Receptor blocking monoclonal antibody with Tacrolimus and Mycophenolate as long term maintenance therapy In patients without rejection steroid usage was limited to the first 7 days post-transplant The current regimen uses Campath-1H which is now well established as an induction agent in renal transplantation for induction with Tacrolimus monotherapy maintenance and an identical short-course steroid regimen
CHARACTERISTICS OF THE TWO REGIMENS TO BE COMPARED
The IL2R MoAbTacrolimusMycophenolateShort-course steroids regimen 2002-2004 Regimen 1 has the advantage of flexibility in terms of adjusting maintenance therapy to allow clinical response to patients and transplants with different tolerance of the two maintenance agents but involves increased expense in terms of using and monitoring the blood levels of two modern and hence expensive agents In addition patients have long-term exposure to the anti-proliferative agent Mycophenolate which can be associated with increased risk of infection gastrointestinal side effects and skin malignancies
The Campath-1HTacrolimusShort-course steroids regimen 2004-current Regimen 2 has the advantage of highly effective immunosuppression in the initial 3-month period allowing lower doses of the potentially nephrotoxic Tacrolimus to be used and simplicity but exposes patients to a period of several months of lymphopenia reduced lymphocyte counts in the blood after Campath administration and reliance on Tacrolimus monotherapy for maintenance which might lead to greater long term Tacrolimus exposure
PROPOSED STUDY
In order to allow a proper comparison of these two anti-rejection treatment combinations we propose a randomised trial which will enable us to consider the relative merits of the two regimens without the introduction of bias associated with using historical control groups Transplant recipients will be randomised in a 12 ratio to regimen 1 and regimen 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-002856-17 | EUDRACT_NUMBER | None | None |