Steroid Avoidance in Leeds with Alemtuzumab or Mycophenolate Mofetil (MMF) Immunosuppression

ISRCTN	ISRCTN94424606
DOI	https://doi.org/10.1186/ISRCTN94424606
Clinical Trials Information System (CTIS)	2006-000830-11
Protocol serial number	RL05/7239
Sponsor	Leeds Teaching Hospitals NHS Trust (UK)
Funder	Leeds Teaching Hospitals NHS Trust (UK) - research fund

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

Renal Unit
Linclon Wing
St James's Hospital
Becket Street
Leeds
LS9 7TF
United Kingdom

Study information

Primary study design	Interventional
Study design	Phase IV, open label, single centre, randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Basiliximab, Tacrolimus, MMF, Alemtuzumab
Primary outcome measure(s)	Diethylene triamine pentaacetate (DTPA) isotopic glomerular filtration rate (GFR) at 12 months
Key secondary outcome measure(s)	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
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Renal Unit

Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes