A facilitated access program to provide Everolimus (RAD) for maintenance for patients completing therapy in RAD trials in solid organ transplantation.

• Register: EUCTR
• Last refreshed on: 2 February 2015
• Main ID: EUCTR2004-001473-25-GB
• Date of registration: 02/09/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A facilitated access program to provide Everolimus (RAD) for maintenance for patients completing therapy in RAD trials in solid organ transplantation.
• Scientific title: A facilitated access program to provide Everolimus (RAD) for maintenance for patients completing therapy in RAD trials in solid organ transplantation.
• Date of first enrolment: 27/10/2008
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001473-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
2. Currently on everolimus (RAD) therapy.
3. Male or female recipients of a solid organ transplant.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Inability or unwillingness to comply with immunosuppressive regimen.
2. Pregnancy.
3. History of acute organ rejection within the last 3 months. These patients may be screened again when they have been without rejection for greater than 3 months.



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

Health Condition(s) or Problem(s) studied

Solid organ transplantation

Intervention(s)

Trade Name: Certican 0.25mg tablets
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Trade Name: Certican 0.5mg tablets
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Certican 0.75mg tablets
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.75-

Trade Name: Certican 1.0 mg tablets
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Primary Outcome(s)

Main Objective: • To facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,
• To provide everolimus maintenance therapy through this access program and
• To collect and review safety data until drug is commercially available or the project has been discontinued.

Secondary Objective: None

Primary end point(s): The primary objectives of this programme are to facilitate the management of patients on maintenance immunosuppression therapy who are completing preceding everolimus trials and to provide everolimus maintenance therapy to them through this access programme. As such there are no outcome measures for
these objectives.

The third primary objective is to collect and review safety data for the 48 month period or until everolimus is commercailly available or the project has been discontinued. For this objective, safety assessments will be conducted over the course of the programme. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, including malignancies, opportunistic infections, graft survival and patient survival.

A blood sample to measure creatinine levels will be collected annually as per protocol for analysis by a central laboratory to assess how the patients kidneys are functioning. Everolimus drug levels will be monitored to ensure that the drug dose is in the target range.

Secondary ID(s)

CRAD001A2401

2004-001473-25-BE