TRIALS I WOULD LIKE TO TRIALS I WOULD LIKE TO SEE IN THE NEXT 5 SEE IN THE NEXT 5

YEARSYEARSPeter J Morris AC, FRSPeter J Morris AC, FRS

Centre for Evidence in TransplantationCentre for Evidence in TransplantationRoyal College of Surgeons Royal College of Surgeons

andandLondon School of Hygiene and Tropical London School of Hygiene and Tropical

MedicineMedicinewww.transplantevidence.comwww.transplantevidence.com

BTS/RA 2013BTS/RA 2013

Question to BTS Question to BTS membersmembers

““Please list one or two trials in Please list one or two trials in organ transplantation that you organ transplantation that you

are feel are needed in the next 5 are feel are needed in the next 5 years”years”

Chris Watson Peter J Morris Chris Watson Peter J Morris President BTS Director CETPresident BTS Director CET

Conflicts of interestConflicts of interest

Chairman DMC for all kidney Chairman DMC for all kidney Belatacept trialsBelatacept trials

Chairman EAB for BIODrIM trialsChairman EAB for BIODrIM trials Chairman EAB for ONE STUDYChairman EAB for ONE STUDY Participant in COPE studyParticipant in COPE study

Suggested TrialsSuggested Trials

Preservation (12)Preservation (12) Antibody (13)Antibody (13) Immunosuppression (9) – induction Immunosuppression (9) – induction

and maintenanceand maintenance Cardiovascular (5) – BP, prevention Cardiovascular (5) – BP, prevention

and heart transplantationand heart transplantation Miscellaneous (10)Miscellaneous (10)

PRESERVATIONPRESERVATIONKIDNEYKIDNEY

HMP vs. cold storageHMP vs. cold storageNormothermic perfusion vs. HMP vs. CS in Normothermic perfusion vs. HMP vs. CS in

DCD/ECD donorsDCD/ECD donorsECMO vs. HMP in DCD donorsECMO vs. HMP in DCD donorsHMP vs. HMP with oxygenationHMP vs. HMP with oxygenation

LIVERLIVERNormothermic vs. CSNormothermic vs. CS

GENERALGENERALRole of stem cells to prevent IR injuryRole of stem cells to prevent IR injury

Antibody (1)Antibody (1)Donor specific antibodiesDonor specific antibodies

-C dependent-C dependent- Luminex- Luminex

-Acute rejection and treatmentAcute rejection and treatment-Chronic rejection – C4d+/Luminex+Chronic rejection – C4d+/Luminex+

-No intervention vs. interventionNo intervention vs. intervention(e.g. plasma exchange, rituximab, (e.g. plasma exchange, rituximab,

bortezomib)bortezomib)

Antibody (2)Antibody (2)SensitisationSensitisation

Failed transplant– nephrectomy vs. Failed transplant– nephrectomy vs. watchful waiting vs. continued ISwatchful waiting vs. continued IS

ABO IABO I-optimal antibody removal-optimal antibody removal

-eculizumab-eculizumab

CardiovascularCardiovascularAggressive BP treatment –ACEi vs. non Aggressive BP treatment –ACEi vs. non

ACEiACEiIdeal BP target ?Ideal BP target ?Aspirin vs. no aspirin - ?protection Aspirin vs. no aspirin - ?protection ?less cancer?less cancerUric acid lowering – CV protection and Uric acid lowering – CV protection and

renal functionrenal functionPrimary heart TP failure - preventionPrimary heart TP failure - prevention

Miscellaneous (1)Miscellaneous (1)GENERALGENERAL

Management of PTLD – EBV+ vs. EBV-Management of PTLD – EBV+ vs. EBV-Psychological preassessment and Psychological preassessment and

compliancecomplianceLIVERLIVER

Liver transplantation for acute alcoholic Liver transplantation for acute alcoholic hepatitishepatitis

PANCREASPANCREASSPK vs. LD kidney TP – long term outcomeSPK vs. LD kidney TP – long term outcome

Miscellaneous (2)Miscellaneous (2)KidneyKidney

Specialist TP unit vs. General surgical unitSpecialist TP unit vs. General surgical unitUse of small paediatric donor kidneysUse of small paediatric donor kidneys

Hyperparathyroidism – Cinacalcet vs PtxHyperparathyroidism – Cinacalcet vs PtxOptimal management of eGFR<35ml/min Optimal management of eGFR<35ml/min

in 1in 1stst year yearEvidence-is being a live kidney donor really Evidence-is being a live kidney donor really

good for donor?good for donor?

Quick check of what Quick check of what RCTs are out there?RCTs are out there?

TRANSPLANT LIBRARYTRANSPLANT LIBRARYavailable to all BTS available to all BTS

members via homepage members via homepage or or

via Institutionvia Institution

My favoured trialsMy favoured trials Azathiaprine vs. MMFAzathiaprine vs. MMF Induction vs. no induction therapy in Induction vs. no induction therapy in

low risk renal transplant recipientslow risk renal transplant recipients Preservation in DCD donors – kidney, Preservation in DCD donors – kidney,

liverliver CNI weaning and BelataceptCNI weaning and Belatacept CNI weaning and tolerance CNI weaning and tolerance

biomarkersbiomarkers Generic immunosuppressive drugs Generic immunosuppressive drugs

e.g.tacrolimuse.g.tacrolimus

The Evidence Hierarchy in Clinical The Evidence Hierarchy in Clinical Practice Practice