Skip to main content

Table 1 Study Flow Sheet—Summary of trial procedures

From: Can regulatory T cells improve outcomes of sensitised patients after HLA-Ab incompatible renal transplantation: study protocol for the Phase IIa GAMECHANgER-1 trial

 

Part 1 (Visit 1&2 n  = 100: Visit 3–7 n  = 9)

Part 2 (Stage 1 n  = 12; Stage 2 n  = 9)

Assessment

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Pre-Part 2 eligibility re-check

Visit 1 leukapheresis

Visit 2 Treg infusion

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Visit 8

Visit windows Part 1—Relative to Visit 3

See below

 + 1 week

 ± 1 dialysis session

 + 2 weeks

 ± 1 dialysis session

 + 4 weeks

 ± 1 dialysis session

 + 8 weeks

 ± 2 dialysis sessions

Within 2 weeks of visit 1 Part 2

        

Visit windows Part 2—Relative to Visit 2

        

See below

See below

 + 1 week

 ± 1 dialysis session

 + 2 weeks

 ± 1 dialysis session

 + 4 weeks

 ± 1 dialysis session

 + 8 weeks ± 2 dialysis sessions

 + 6 months ± 3 dialysis sessions

 + 12 months

 ± 3 dialysis sessions

Part 1 ( n  = 100)

 Registration Form & Consent

x

               

 Check / Re-check Inclusion/Exclusion Criteria

x

      

x

        

 Post-consent eligibility tests in some recruits*

                

 HIV, HepBSAg, HepC

x

               

 Liver function tests

x

      

x

        

 ECG

x

      

x

        

 Pregnancy test

x

      

x

        

 Medical and transplant history, including route of HLA sensitisation

x

      

x

        

 Record / update demographic data

x

      

x

        

 Blood sample for in vitro dual Fluorospot (in all)

x

               

 Inform patient of Fluorospot pattern (End of study if ineligible for Part 2)

 

x

              

 Baseline Immune monitoring (in first 9 recruits with fluorospot pattern eligible for Part 2) (n = 9)

  

x

x

x

x

x

         

 Physical exam

       

x

        

 Vital signs: pulse, temperature, BP

  

x

x

x

x

x

x

        

 Monitoring of AE and IME related to study procedures (i.e. blood test)

 

x

x

x

x

x

x

x

        

Part 2 (Stage 1 n  = 12; Stage 2 n  = 9)

 Leukapheresis

        

x

       

 Symptoms-directed physical exam†

        

x

x

x

x

x

x

x

x

 Vital signs: pulse, temperature, BP

        

x

x

x

x

x

x

x

x

 Blood tests according to EU Tissues and Cells Directive #

        

x

       

 Treatment Immune monitoring

         

x

x

x

x

x

x

x

 Full blood count, U&E, LFTs, CRP§

         

x

x

x

x

x

x

x

 Record Concomitant medication

         

x

x

x

x

x

x

x

 Monitoring of AE and IME related to study procedures

        

x

       

 Full AE and IME monitoring starts at time of TR001 infusion

         

x

x

x

x

x

x

x

 Pregnancy test

               

x

  1. Part 1
  2. Visit 1 – At time of recruitment, or next convenient dialysis session if additional post-consent eligibility tests need doing. (Fluorospot only)
  3. Visit 2 – Once visit 1 fluorospot results available No blood tests
  4. Visit 3 – Week ‘0’. Once conditions to proceed with baseline immune monitoring have been met (see Sect. 7.1) (Fluorospot, HLA Ab, Treg numbers and phenotype) –
  5. Visit 4 – 1 week after visit 3 ± 1 dialysis session (Fluorospot, HLA Ab, Treg numbers and phenotype)
  6. Visit 5 – 2 weeks after visit 3 ± 1 dialysis session (Fluorospot only)
  7. Visit 6 – 4 weeks after week 0 ± 1 dialysis session (Fluorospot, HLA Ab, Treg numbers and phenotype)
  8. Visit 7 – 8 weeks after week 0 ± 2 dialysis sessions (Fluorospot, HLA Ab, Treg numbers and phenotype)
  9. Pre-Part 2 eligibility re-check – to be performed approximately 2 weeks prior to leukapheresis
  10. Part 2
  11. Visit 1 – Leukapheresis – at a time convenient for the patient
  12. Visit 2 – Treg infusion – at a time convenient for the patient once Tregs are ready – blood for Fluorospot assay, HLA Ab and determination of Treg numbers and phenotype taken pre-Treg infusion – Sample may be taken at the dialysis session before Treg infusion
  13. Visit 3 – 1 week after Treg infusion ± 1 dialysis session (Fluorospot, HLA Ab, Treg numbers and phenotype)
  14. Visit 4 – 2 weeks after Treg infusion ± 1 dialysis session (Fluorospot)
  15. Visit 5 – 4 weeks after Treg infusion ± 1 dialysis session (Fluorospot, HLA Ab, Treg numbers and phenotype)
  16. Visit 6 – 8 weeks after Treg infusion ± 2 dialysis sessions (Fluorospot, HLA Ab, Treg numbers and phenotype)
  17. Visit 7 – 6 months after Treg infusion ± 3 dialysis sessions (Fluorospot, HLA Ab)
  18. Visit 8 – 12 months after Treg infusion ± 3 dialysis sessions (Fluorospot, HLA Ab)
  19. * Post-consent eligibility tests in some recruits—Take HIV, HepBSAg, Hep C in all unless negative test results are available in last 5 years. Take LFTs in all unless results are available in last 3 months. Do ECG unless a SOC ECG within the last 3 months is available for review. Do pregnancy test on all women of child-bearing potential
  20. * Repeat eligibility tests in some patients at pre-Part 2 assessment. Take LFTs in all unless results are available in last 3 months. Do ECG unless a SOC ECG within the last 3 months is available for review. Do pregnancy test on all women of child-bearing potential
  21. † In all the post-TR001 infusion visits, the need for a symptoms-directed physical examination and/or symptom-specific tests will be determined according to standard medical care
  22. # Mandatory serological tests (Anti-HIV-1, 2, HBsAg, Anti HBc, Anti-HCV-Ab, T. pallidum-specific test) are supplemented with HTLV-I/II antibody testing. Window for performing is within 7 days after leukapheresis
  23. § Send sample for FBC, U&E, LFTs and CRP at every visit, unless results available from a dialysis session within the visit window
  24. Visit Schedule and immune monitoring tests
Back to article page

BMC Nephrology

ISSN: 1471-2369

Contact us