Renal Transplant RejectionPhase 3IBERICANCT01324934
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
A Phase 3 study testing ATG-Fresenius S in people with Renal Transplant Rejection, run by Neovii Biotech at 10 sites in 2 countries.
Trial summary
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- ATG-Fresenius S
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2006to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Signed and dated informed consent form,
- End-stage renal disease,
- Candidates for a first transplantation,
- Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons,
- Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours,
- Male or female patients between 18 to 75 years of age inclusive,
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- Patients able to comply with all study related requirements,
- Patients able to receive oral medication,
- Women of childbearing age with a safe contraceptive method throughout the study.
Who cannot join
- Women who are pregnant or breast feeding,
- Known Human Immunodeficiency Virus,
- Hepatitis B Virus or Hepatitis C Virus infection,
- Severe actual viral, bacterial or fungal infection not adequately controlled,
- Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol,
- Patients at high immunological risk defined as current PRA > 25% or historical PRA > 50%,
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- Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids,
- Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission),
- Patients with previous transplantation except 1st graft loss due to surgical complications,
- Patients receiving combined transplantation,
- Patients with major organ dysfunctions,
- Serious psychiatric or psychological disorders,
- Pre-transplant thrombocytopenia: < 50,000 thrombocytes/µl, Pre-transplant leukopenia: < 2,000 leukocytes/µl,
- Unable or unwilling to comply fully with the protocol,
- Participation in another study of an investigational medicinal product concurrently or within the last 30 days.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Spain6 sites
Hospital Universitario Juan Canalejo
A Coruña, 15006
Hospital Universitari Clinic i Provincial
Barcelona, 08036
Hosptial Gregorio Maranon
Madrid, 28007
Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Portugal4 sites
Centro Hospitalar de Lisboa Ocidental
Carnaxide, 2799-523
Hospitais da Universidade de Coimbra
Coimbra, 3000-075
Hospital de Curry Cabral
Lisbon, 1069-166
Hospital Geral de Santo António, SA
Porto, 4090-001
About this study
Official title: Prospective, Randomized, Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of Immunosuppression Following a Heart-beating Cadaveric Renal Transplantation Based on the Use of Rabbit Anti-T-lymphocyte Serum, Tacrolimus and Mycophenolate, Free of Concomitant Corticosteroids From the Start of Immunosuppression
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.
- Conditions
- Renal Transplant Rejection
- Being tested
- ATG-Fresenius S
- Keywords
- acute rejection, chronic rejection, subclinical rejection, renal transplantation, steroid-free, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-Fresenius SDrug
Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory.
(In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids).
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic Receives: Drug: ATG-Fresenius S |
| Control Group | No intervention | immunosuppressive treatment consisting of TAC, MMF or Myfortic, and corticosteroids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection
Measured: 1 year
Secondary outcomes (5)
Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections
Measured: 1 year
Incidence and duration of initial DGF
Measured: 1 year
Renal function
Measured: 1 year
Patient and Graft survival
Measured: 1 year
Safety endpoints are the incidence of AEs/SAEs and ADRs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startOct 2006
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Recruitment became very slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant RejectionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovii Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda, Recerca Clínica S.L., PsyConsult
- Responsible party
- Sponsor
- Investigators
- Manuel Rengel, Dr, Principal investigator, Hosptial Gregorio Maranon, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324934
- Sponsor's protocol ID
- AP-AS-24-ES
- Acronym
- IBERICA
- Status last verified
- Apr 2015
- First submitted
- 21 Mar 2011
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of Immunosuppression Following a Heart-beating Cadaveric Renal Transplantation Based on the Use of Rabbit Anti-T-lymphocyte Serum, Tacrolimus and Mycophenolate, Free of Concomitant Corticosteroids From the Start of Immunosuppression
- ClinicalTrials.gov ID
- NCT01324934
- Acronym / sponsor ID
- IBERICA / AP-AS-24-ES
- Conditions
- Renal Transplant Rejection
- Keywords
- acute rejection, chronic rejection, subclinical rejection, renal transplantation, steroid-free, kidney transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment became very slow.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Neovii BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda, Recerca Clínica S.L., PsyConsult
- Study start
- Oct 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Drug: ATG-Fresenius Simmunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic |
| Control Group | No intervention | –immunosuppressive treatment consisting of TAC, MMF or Myfortic, and corticosteroids. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form,
- End-stage renal disease,
- Candidates for a first transplantation,
- Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons,
- Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours,
Key exclusion criteria (15 listed)
- Women who are pregnant or breast feeding,
- Known Human Immunodeficiency Virus,
- Hepatitis B Virus or Hepatitis C Virus infection,
- Severe actual viral, bacterial or fungal infection not adequately controlled,
- Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol,
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 |
|---|---|---|
| ATG-Fresenius SDosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory. (In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids). | Drug | Study Group |
Primary outcome
The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection
Time frame: 1 year
5 secondary outcomes
Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections
Time frame: 1 year
Incidence and duration of initial DGF
Time frame: 1 year
Renal function
Time frame: 1 year
Patient and Graft survival
Time frame: 1 year
Safety endpoints are the incidence of AEs/SAEs and ADRs
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Recruitment became very slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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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.
Manuel Rengel, Dr principal investigator
Hosptial Gregorio Maranon, Madrid, Spain
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ATG-Fresenius S in people with Renal Transplant Rejection, run by Neovii Biotech at 10 sites in 2 countries.
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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Portugal. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment became very slow.). Results are not available in the source record.
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?
The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection (time frame: 1 year). 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 1 May 2015.