Steroid Avoidance in Leeds with Alemtuzumab or Mycophenolate Mofetil (MMF) Immunosuppression
| ISRCTN | ISRCTN94424606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94424606 |
| EudraCT/CTIS number | 2006-000830-11 |
| Secondary identifying numbers | RL05/7239 |
- Submission date
- 28/02/2006
- Registration date
- 23/03/2006
- Last edited
- 25/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Baker
Scientific
Scientific
Renal Unit
Linclon Wing
St James's Hospital
Becket Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Phase IV, open label, single centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | SALAMI |
| Study objectives | To compare the efficacy of two tacrolimus based steroid avoidance regimes. This is an equivalence study with no anticipated difference in major endpoints between the two arms. |
| Ethics approval(s) | Ethics approval received from the Leeds (East) Research Ethics Committee on the 26th July 2006 (ref: 06/Q1206/64, EudraCT No: 2006-000830-11). |
| Health condition(s) or problem(s) studied | Renal transplant immunosuppression |
| Intervention | Comparing two immunosuppression regimes: 1. Control (standard regime) - intra-operative Basiliximab and steroids followed by maintenance with Tacrolimus and MMF 2. Steroids intra-operative followed by Alemtuzumab then maintenence with Tacrolimus |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Basiliximab, Tacrolimus, MMF, Alemtuzumab |
| Primary outcome measure | Diethylene triamine pentaacetate (DTPA) isotopic glomerular filtration rate (GFR) at 12 months |
| Secondary outcome measures | 1. Patient and graft survival 2. Incidence and duration of delayed graft function 3. Incidence and severity of steroid-treated presumptive and biopsy-confirmed acute rejection 4. Comparison of blood pressure control between groups by clinic readings, number of agents used and 24 hour monitoring at 6 and 12 months 5. Comparison of groups by pulse wave analysis, a powerful surrogate marker for cardiovascular outcome, at baseline, 6 and 12 months 6. Incidence of impaired glucose tolerance, weight gain and diabetes at 6 weeks, 6 and 12 months 7. Assessment of quality of life by questionnaires at 6 and 12 months 8. Assessment of adherence, looking at trough tacrolimus level variations between two groups 9. Economic analysis of the cost-effectiveness of both regimes 10. Comprehensive assessment of clinically indicated, implantation and one year protocol biopsies by: 10.1. Morphological scoring by Banff/chronic allograft damage index (CADI) system 10.2. Assessment of fibrosis by specific stains 10.3. Genomic analysis for products associated with ischaemia reperfusion, immune activation, inflammation and fibrosis 11. Analysis of urine and blood by proteomics at baseline, 3 months, 6 months, 12 months and other clinically indicated time points 12. Analysis of T cells for development of regulatory T cells 13. Analysis of anti-donor antibody responses 14. Monitoring of B and T cell subsets by flow cytometry 15. Monitoring of infectious complications/pathogens - including cytomegalovirus (CMV) infection and infections with polyomaviruses 16. Incidence of post transplant malignancies including post-transplant lymphoproliferative disease (PTLD) 17. Biochemical and haematological monitoring |
| Overall study start date | 01/04/2006 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Male and female patients who must be over age 18 years 2. Patients must be recipients of heart-beating cadaveric, non-heart beating or living donors 3. Patients receiving a 2nd or subsequent grafts must have maintained their primary graft for a minimum of 6 months, except if graft failure was due to technical reasons 4. Written informed consent 5. Women at risk of pregnancy must have a negative pregnancy test before commencing the trial and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuing the trial. The manufacturer of Alemtuzumab advises effective contraception for 6 months after administration to men or women. Advice will be given to patients to discuss with the transplant medical staff if a pregnancy is planned. |
| Key exclusion criteria | 1. Regional patients from Hull Royal Infirmary (due to the logistical difficulties in following these patients up from Leeds) 2. High Risk Recipients - defined as recipients who have one or more of the following: 2 human leukocyte antigen, type DR (HLA-DR) mismatch, previous immunologically mediated graft loss in less than 6 months, preoperative donor specific antibodies 3. Known hypersensitivity to the investigational medicinal product (IMP) including the standard drugs 4. Prohibited prior or concomitant medications 5. Pregnant women or nursing mothers 6. White blood cell count (WBC) count <3000/mm^3 or platelets <75,000/mm^3 at time of study entry 7. Any other concurrent cardiovascular, gastrointestinal, pulmonary or haematological conditions that would restrict the administration of study drugs in the opinion of the investigator |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Renal Unit
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Dept.
6th Floor Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
England
United Kingdom
| Website | http://www.leedsth.nhs.uk/sites/research_and_development/ |
|---|---|
"ROR" |
https://ror.org/00v4dac24 |
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK) - research fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2012 | Yes | No | |
| Results article | results | 27/12/2013 | Yes | No |
