Liver TransplantationPhase 4NCT00332462
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
A Phase 4 study testing Cyclosporine (Sandimmun® i.v.) and Cyclosporine (Sandimmun® Optoral) in people with Liver Transplantation, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Cyclosporine (Sandimmun® i.v.) and Cyclosporine (Sandimmun® Optoral)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- May 2006to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- About to undergo a primary liver transplant (including living donor, split liver).
- Expected to be capable of study participation for full 6 months post-transplantation.
- Allograft biopsies will be possible.
Who cannot join
- The surgery is a multi-organ transplant.
- The patient has previously been transplanted with any other organ.
- The graft derives from a non-heart beating donor.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label, Exploratory Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine During the First 7 Days Post Transplant Followed by Treatment With Cyclosporine Micro Emulsion in de Novo Liver Transplant Recipients
The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.
- Conditions
- Liver Transplantation
- Being tested
- Cyclosporine (Sandimmun® i.v.), Cyclosporine (Sandimmun® Optoral)
- Keywords
- Liver transplantation, Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine (Sandimmun® i.v.)Drug
Also called Sandimmun
Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Cyclosporine (Sandimmun® Optoral)Drug
Also called Sandimmun
Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine (Sandimmun®) | Experimental | Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. Receives: Drug: Cyclosporine (Sandimmun® i.v.); Drug: Cyclosporine (Sandimmun® Optoral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation
Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.
Measured: 3 months
Secondary outcomes (1)
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation
The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.
Measured: 3 or 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332462
- Sponsor's protocol ID
- COLO400ADE01
- Status last verified
- Mar 2011
- First submitted
- 30 May 2006
- Last updated
- 7 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Exploratory Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine During the First 7 Days Post Transplant Followed by Treatment With Cyclosporine Micro Emulsion in de Novo Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT00332462
- Acronym / sponsor ID
- COLO400ADE01
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, Cyclosporine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Jun 2006 (estimated)
- Results
- Posted 11 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine (Sandimmun®) | Experimental | Drug: Cyclosporine (Sandimmun® i.v.), Drug: Cyclosporine (Sandimmun® Optoral)Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- About to undergo a primary liver transplant (including living donor, split liver).
- Expected to be capable of study participation for full 6 months post-transplantation.
- Allograft biopsies will be possible.
Key exclusion criteria (4 listed)
- The surgery is a multi-organ transplant.
- The patient has previously been transplanted with any other organ.
- The graft derives from a non-heart beating donor.
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine (Sandimmun® i.v.)Also: SandimmunCyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. | Drug | Cyclosporine (Sandimmun®) |
| Cyclosporine (Sandimmun® Optoral)Also: SandimmunSandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. | Drug | Cyclosporine (Sandimmun®) |
Primary outcome
Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation
Time frame: 3 months
Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.
1 secondary outcome
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation
Time frame: 3 or 6 months after transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine (Sandimmun® i.v.) and Cyclosporine (Sandimmun® Optoral) in people with Liver Transplantation, run by Novartis Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.