Study identification

EU PAS number

EUPAS37025

Study ID

47431

Official title and acronym

A non-interventional post-authorization safety study (NI-PASS) of outcomes associated with the use of tacrolimus around conception, or during pregnancy or lactation using data from Transplant Pregnancy Registry International (TPRI)

DARWIN EU® study

No

Study countries

United States

Study description

The primary purpose of this study was to estimate prevalence of major malformations (as a combined group) among children born to female transplant recipients using tacrolimus-containing-regimens (or alternative immunosuppressants, as a combined group) during the period from 6 weeks prior to conception to the end of the first trimester without use of mycophenolic acid (MPA).
Similarly, for minor malformations (as a combined group).
This study also described the distribution of types of malformations among children born to female transplant recipients using tacrolimus (or alternative immunosuppressants as a combined group).
Additional objectives evaluated prevalence of spontaneous abortions, still births, small for gestational age, gestational diabetes mellitus, gestational hypertension and pre-eclampsia.
TRPI is based in the United States and includes self-reported data from individuals from any country based on a minimum set of criteria.

Study status

Finalised

Contact details

Michael Moritz

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe B.V.
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)