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Immunosuppressive drug bioequivalence in kidney transplant recipients – Prograf and CellCept

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521800-22-00
Acronym
GenIS-BID
Enrollment
27
Registered
2025-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-04

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

Conditions

Organ transplantation

Brief summary

AUC0-12 and Cmax of Tac and MPA test:reference (according to EMA bioequivalence guidelines).

Detailed description

Tac and MMF pharmacokinetic parameters and variables such as AUC0-12, Cmax, C0, C12, CL/F, popPK model parameters, metagenomic feces analyses, feces derived ex vivo drug conversion rates.

Interventions

DRUGTacrolimus Ascend 1 mg Hartkapseln
DRUGMycophenolate Mofetil Accord 250 mg kapselit
DRUGPROGRAF 1 mg capsule
DRUGCellCept 500 mg film-coated tablets

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
AUC0-12 and Cmax of Tac and MPA test:reference (according to EMA bioequivalence guidelines).—

Secondary

MeasureTime frame
Tac and MMF pharmacokinetic parameters and variables such as AUC0-12, Cmax, C0, C12, CL/F, popPK model parameters, metagenomic feces analyses, feces derived ex vivo drug conversion rates.—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026