Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE

Table 1 Schedule of monitoring over the course of MDR-105-SAE

Study visit year	1		2	3	4	5	6	7
Study visit number	0	1	2	3	4	5	6	7
Study visit window (months)	+ 3	± 1	± 1	± 1	± 1	± 1	± 1	± 1
Assessment	Screening	Post enrollment
Informed consent	⦁
Confirm study eligibility criteria	⦁
Demographics	⦁
Baseline characteristics	⦁
Medical history	⦁
Prior/concomitant medication	⦁	⦁	⦁	⦁	⦁	⦁	⦁	⦁
Perform complete physical examination	⦁	⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record vital signs	⦁	⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record weight	⦁	⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record height	⦁
Hematology panel^a		L	L	L	L	L	L	L
Comprehensive metabolic panel^a		L	L	L	L	L	L	L
Urinalysis		L	L	L	L	L	L	L
Calcineurin inhibitor trough levels^b		L	L	L	L	L	L	L
Mixed chimerism testing^c		C	C	C	C	C	C	C
Record instances of acute rejection requiring treatment		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record instances of proteinuria		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Kidney biopsy^d		Only for cause
Complete subject status form		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record all SAEs		⦁ (ongoing)
Record AEs leading to study withdrawal		⦁ (as needed)
Record history of hospitalizations since transplant		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record development of NODAT^e		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record development of GVHD		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record instances of BK viremia development		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record instances of dnDSA		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record instances of cardiovascular events^f		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record instances of opportunistic infection		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record instances of PTLD/other malignancies		⦁	⦁	⦁	⦁	⦁	⦁	⦁
Record instances of MDS		⦁	⦁	⦁	⦁	⦁	⦁	⦁

AE adverse effects, C central laboratory, dnDSA de novo DSA, L local laboratory, MDS myelodysplastic syndrome, NODAT new-onset diabetes after transplantation, PTLD post-transplant lymphoproliferative disease
^aTesting will be completed at each follow-up visit and will be analyzed locally using accepted laboratory methodology
^bFor subjects who have discontinued CNI, compliance check is performed as needed to assess trough levels locally, per standard accepted laboratory methodology. CNI trough levels will be assessed in all recipients at each follow-up visit for subjects taking CNI
^cThe degree of donor chimerism in recipient blood will be by central laboratory. Subjects who have lost mixed chimerism (< 5%) do not need to repeat testing at subsequent visits
^dTransplant kidney biopsy will be performed for cause at the discretion of a subject’s treating physician and will undergo local pathology review
^eNODAT will be determined based on need for use of an antidiabetic agent for more than 30 days, or 2 fasting plasma glucose levels ≥ 126 mg/dL in a subject who was not diabetic at study entry
^fCardiovascular events include acute myocardial infarction, stroke, acute peripheral arterial occlusion, and revascularization procedure

ISSN: 1745-6215