World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 8 January 2018
Main ID:  EUCTR2016-004507-31-FR
Date of registration: 02/02/2017
Prospective Registration: Yes
Primary sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Public title: N/A
Scientific title: N/A - TIGER
Date of first enrolment: 27/01/2017
Target sample size: 122
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004507-31
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
France
Contacts
Name: DRCD Hôpital St Louis   
Address:  1 av. Claude Vellefaux 75010 PARIS France
Telephone:
Email: aurelie.guimfack@aphp.fr
Affiliation:  ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Name: DRCD Hôpital St Louis   
Address:  1 av. Claude Vellefaux 75010 PARIS France
Telephone:
Email: aurelie.guimfack@aphp.fr
Affiliation:  ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Key inclusion & exclusion criteria
Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 122
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied

MedDRA version: 19.1 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Intervention(s)

Trade Name: METHYLPREDNISOLONE MYLAN Générique
Product Name: METHYLPREDNISOLONE MYLAN Générique
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Methylprednisolone
Other descriptive name: Methylprednisolone
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range

Trade Name: PREDNISONE ARROW 20mg
Product Name: PREDNISONE ARROW 20mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal

Trade Name: PREDNISONE ARROW 5 mg
Product Name: PREDNISONE ARROW 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone 5 mg
Other descriptive name: Prednisone 5 mg
Concentration unit: mg milligram(s)
Concentration type: equal

Primary Outcome(s)
Main Objective:
Primary end point(s):
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
P140931
Source(s) of Monetary Support
DGOS
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history