ICTRP Search Portal

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:	1 May 2012
Main ID:	EUCTR2005-000350-69-DE
Date of registration:	09/05/2006
Prospective Registration:	Yes
Primary sponsor:	Novartis Pharma Services AG
Public title:	A two-year extension to a one-year, multicenter, open-label, randomized study to evaluate the safety and efficacy of FTY720 combined with tacrolimus and steroids versus MMF (Cellcept) combined with tacrolimus and steroids, in de novo adult renal transplant recipients.
Scientific title:	A two-year extension to a one-year, multicenter, open-label, randomized study to evaluate the safety and efficacy of FTY720 combined with tacrolimus and steroids versus MMF (Cellcept) combined with tacrolimus and steroids, in de novo adult renal transplant recipients.
Date of first enrolment:
Target sample size:	140
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000350-69
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: yes Placebo: no Other: no
Phase:

Countries of recruitment
Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
a) The patient has given written informed consent to participate in the extension study.
b) The patient has completed the Month 12 visit of the core study either on or off study medication.
c) Females capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Not applicable.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

De novo kidney transplantation

Intervention(s)

Product Name: FTY720
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Product Name: FTY720
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: CellCept 250 mg Kapseln
Product Name: CellCept
Product Code: RS61143
Pharmaceutical Form: Capsule*
INN or Proposed INN: Mycophenolat mofetil
CAS Number: 115007-34-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Trade Name: Prograf 0.5 mg Kapseln
Product Name: Prograf
Product Code: FK-506
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tacrolimus
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Prograf 1 mg Kapseln
Product Name: Prograf
Product Code: FK-506
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tacrolimus
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Prograf 5 mg Kapseln
Product Name: Prograf
Product Code: FK-506
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tacrolimus
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): treated biopsy proven acute rejection, graft loss, death, or premature discontinuation from study

Secondary Objective: The secondary objectives are to provide long-term information under continued study medication beyond 12 months post transplantation on all other efficacy and safety parameters (as per original protocol).

Main Objective: The objective of this extension is to assess long term efficacy and safety of FTY720 combined with corticosteroids and tacrolimus versus MMF combined with corticosteroids and tacrolimus in de novo adult renal transplant recipients beyond 12 months post-transplantation and to provide continued treatment for patients who have completed the 12-month core study on study medication.
The key efficacy parameter is the incidence over the 36 months of the composite end-point of treated biopsy proven acute rejection, graft loss, death, or premature discontinuation from study. The key safety parameters include renal, cardiac and pulmonary function, infections and malignancies.

Secondary Outcome(s)

Secondary ID(s)

FTY720A2302E01

Source(s) of Monetary Support

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.