Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000006

EU PAS number

EUPAS1000000006

Study ID

1000000006

Official title and acronym

TAK-620-4007: Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Endstage Renal Disease (ESRD) or Comorbid Severe Chronic Renal Disease Requiring Peritoneal Dialysis or Hemodialysis

DARWIN EU® study

No

Study countries

Austria
Belgium
Denmark
Estonia
France
Germany
Italy
Spain
United Kingdom

Study description

The main aim of this study is to assess the safety profile of maribavir when treating refractory cytomegalovirus (CMV) infection after transplantation in adults with kidneys that are no longer functioning on their own (also called end-stage renal disease or ESRD) or have severe chronic kidney disease requiring artificial filtering of the kidney (dialysis) or the blood (hemodialysis).

In this study, already existing data will be collected from the participant’s medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.

Study status

Planned

Contact details

Study Contact Takeda

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
Study protocol
Initial protocol

TAK-620-4007 PASS Protocol 02Jun2023 SR_Redacted.pdf

English (682.19 KB - PDF)View document
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)