An integrated immunological-pharmacological approach to improve long-term allograft function

An integrated immunological-pharmacological approach to improve long-term allograft function - Parameters to improve long-term allograft function

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45414

Enrollment

420

Registered

2017-02-08

Start date

2017-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

graft failure kidney transplantation

Interventions

B-cell memory

kidney transplantation

tacrolimus intra-patient variability

T-cell memory

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Adult recipients (18 years or older) who were 5 to 7 years after kidney transplantation.

Exclusion criteria

Exclusion criteria: ABO-incompatible kidney transplants. Recipients of a non-renal transplant.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is donor-specific T-cell and B-cell memory function in relation to Tac IPV.	—

Secondary

Measure	Time frame
The secondary endpoints: - The difference in the development of CRAD between in patients with high IPV Tac and low IPV Tac. Kidney function and CRAD will be defined by the GFR determined at 6 months, 1, 3, and 5 years after transplantation. - The T-cell receptor and B-cell receptor signature in relation to Tac IPV - Intra-lymphocytic Tac concentrations in relation to Tac IPV and immunologic parameters	—

Measure

Time frame

The secondary endpoints: - The difference in the development of CRAD between in patients with high IPV Tac and low IPV Tac. Kidney function and CRAD will be defined by the GFR determined at 6 months, 1, 3, and 5 years after transplantation. - The T-cell receptor and B-cell receptor signature in relation to Tac IPV - Intra-lymphocytic Tac concentrations in relation to Tac IPV and immunologic parameters

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)