Optimize

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12]

Trial duration

22 Jul 2019 → 14 Apr 2025

Decision date (initial)

2024-11-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516509-22-00

EudraCT number

2018-003194-10

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

The overall primary study endpoint “successful transplantation” as defined for the individual strata and analyzed for the whole study population.
Stratum A: Primary endpoint: successful transplantation at two years after transplantation defined as: absence of graft or patient loss in the presence of an eGFR above 30 ml/min/1.73m2.
Stratum B: Primary endpoint: successful transplantation at two years after transplantation defined as absence of graft or patient loss in the presence of an eGFR above 45 ml/min/1.73m2.

Secondary objectives 1

1. Successful transplantation analyzed separately per stratum

Conditions and MedDRA coding

kidney transplant

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Written informed consent must be obtained before any assessment is performed
2. Male or female subject ≥65 years old
3. Subject randomized within 24 hours of completion of transplant surgery
4. Stratum A: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged 65 years or older
5. Stratum B: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged below 65 years or a living donor of any age

Exclusion criteria 13

1. Subject is a multi-organ transplant recipient
2. Recipient of bloodgroup ABO incompatible allograft or CDC cross-match positive transplant
3. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity
4. Recipient of a kidney with a cold ischaemia time (CIT) >24 hr
5. Recipients of a kidney from an HLA-identical related living donor
6. Known intolerability for one or more of the study drugs
7. Subject who is HIV positive
8. HBsAg and/or a HCV positive subject with evidence of elevated liver function tests (ALT/AST levels ≥2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable
9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV)
10. Subject with severe systemic infections, current or within the two weeks prior to randomization
11. Subject with severe restrictive or obstructive pulmonary disorders
12. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled
13. Subject with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 14

1. Incidence of individual endpoints of death, graft loss, eGFR below 30 or 45 ml/min/1.73m2 at Months 12 and 24
2. Incidence of treated biopsy-proven rejection (tBPAR)
3. Rejection treatment and type of rejection treatment
4. The evolution of renal function (eGFR and creatinine clearance) over time by slope analysis
5. The incidence of adverse events, serious adverse events and adverse reactions
6. The incidence of clinically relevant infections, post transplantation diabetes mellitus, malignancies and cardiovascular events
7. Presence of frailty at 12 and 24 months after transplantation and change in frailty from baseline
8. Presence of markers for immunosenescence at 12 and 24 months and changes from baseline
9. HRQoL at 0, 12 and 24 months and changes from baseline
10. Development of donor-specific anti-HLA antibodies (DSA)
11. Difference in illness perception at 0, 12 and 24 months and changes from baseline
12. Difference in BAASIS at 12 and 24 months
13. Difference in symptoms (DSI + MTSOSD-59) at 0, 12 nad 24 months and changes from baseline
14. Difference in iBOX predicted outcome at 3, 5 and 7 years

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

S.P. Berger

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

S.P. Berger

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications