Non-interventional Post Authorization Safety Study (PASS) to evaluate hypersensitivity reactions associated with administration of intravenous iron sucrose in Chronic Kidney Disease (CKD) patients, under dialysis or not

Study identification

• EU PAS number:
  EUPAS16600
• Study ID:
  18174
• Official title and acronym:
  Non-interventional Post Authorization Safety Study (PASS) to evaluate hypersensitivity reactions associated with administration of intravenous iron sucrose in Chronic Kidney Disease (CKD) patients, under dialysis or not
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  No information provided.
• Study status:
  Planned

Research institutions and networks

Institutions

Phaze Clinical Research and Pharma Consulting

Study timelines

Date when funding contract was signed

Actual:01/04/2016

Study start date

Planned:31/03/2017

Date of final study report

Planned:01/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Cooper Α.Ε., Demo Α.B.E.Ε., Help ABEE, Propius P.C., Target Pharma ΜΕΠΕ, UNI-PHARMA ΚΛΕΩΝ ΤΣΕΤΗΣ ΦΑΡΜΑΚΕΥΤΙΚΑ ΕΡΓΑΣΤΗΡΙΑ ΑΒΕΕ

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)