Transplantation, KidneyPhase 4NCT00861536
Comparison of ATG to Thymoglobuline in Renal Transplantation
A Phase 4 study testing ATG Fresenius and Thymoglobuline Genzyme in people with Transplantation, Kidney, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Kidney
- What is being tested?
- ATG Fresenius and Thymoglobuline Genzyme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Feb 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients, who are at least 18 years or older and have a high immunological risk defined by:
- The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are
- For class I below the threshold of detection of a current CDC T-cell-/ and B-cell cross-match
- For class II below the threshold of detection of a current CDC B-cell cross-match.
- Patient receives a renal allograft only.
- Female patients of child bearing age agree to maintain effective birth control practice during the study.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Who cannot join
- Patient is pregnant or breastfeeding.
- Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
- Patient and donor have a positive T-cell crossmatch.
- Patient and donor are ABO incompatible.
- Patient with combined transplantation.
- Age of donor >75 years.
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- Cold ischemia time >40 hours.
- Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
- Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
- Patient is allergic or intolerant to ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.
- EBV risk constellation (recipient EBV negative and donor EBV positive).
- Patient or donor is known to be HIV positive.
- Patient has a liver disease, defined as continuously having ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3fold of the upper value of the normal range of the investigational site during the past 28 days.
- Patient with malignancy or history of malignancy <2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
- Patient is unlikely to comply with the visits schedule in the protocol.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Transplantation Immunology and Nephrology
Basel, 4031
About this study
Official title: An Open, Multicenter, Randomised, Parallel Group Pilot Study to Investigate Two Different Polyclonal Rabbit Immunoglobulin Preparations for Safety and Efficacy:A Comparison of ATG-Fresenius S to Thymoglobulin in Prophylaxis for Immunological High Risk Patients Following Renal Transplantation
An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.
- Conditions
- Transplantation, Kidney
- Being tested
- ATG Fresenius, Thymoglobuline Genzyme
- Keywords
- risk factors, immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG FreseniusDrug
Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d
Thymoglobuline GenzymeDrug
Day 0-3: 1.5 mg/kg bw/d
| Study group | Role | What they receive |
|---|---|---|
| ATG Fresenius | Experimental | Not described Receives: Drug: ATG Fresenius |
| Thymoglobuline Genzyme | Active comparator | Not described Receives: Drug: Thymoglobuline Genzyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Daily
Secondary outcomes (4)
Rejection
Measured: Daily
Graft function
Measured: Daily
Patient survival
Measured: Daily
Graft survival
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, KidneyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juerg Steiger, MD,Prof, Principal investigator, University Hospital Basel, Transplantation Immunology and Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861536
- Sponsor's protocol ID
- 82/06
- Status last verified
- Apr 2015
- First submitted
- 12 Mar 2009
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter, Randomised, Parallel Group Pilot Study to Investigate Two Different Polyclonal Rabbit Immunoglobulin Preparations for Safety and Efficacy:A Comparison of ATG-Fresenius S to Thymoglobulin in Prophylaxis for Immunological High Risk Patients Following Renal Transplantation
- ClinicalTrials.gov ID
- NCT00861536
- Acronym / sponsor ID
- 82/06
- Conditions
- Transplantation, Kidney
- Keywords
- risk factors, immunology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Mar 2009 (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.
An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG Fresenius | Experimental | Drug: ATG Fresenius |
| Thymoglobuline Genzyme | Active comparator | Drug: Thymoglobuline Genzyme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Recipients, who are at least 18 years or older and have a high immunological risk defined by:
- The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are
- Patient receives a renal allograft only.
- Female patients of child bearing age agree to maintain effective birth control practice during the study.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Key exclusion criteria (16 listed)
- Patient is pregnant or breastfeeding.
- Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
- Patient and donor have a positive T-cell crossmatch.
- Patient and donor are ABO incompatible.
- Patient with combined transplantation.
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 FreseniusDay 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d | Drug | ATG Fresenius |
| Thymoglobuline GenzymeDay 0-3: 1.5 mg/kg bw/d | Drug | Thymoglobuline Genzyme |
Primary outcome
Adverse events
Time frame: Daily
4 secondary outcomes
Rejection
Time frame: Daily
Graft function
Time frame: Daily
Patient survival
Time frame: Daily
Graft survival
Time frame: Daily
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Juerg Steiger, MD,Prof principal investigator
University Hospital Basel, Transplantation Immunology and Nephrology
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 ATG Fresenius and Thymoglobuline Genzyme in people with Transplantation, Kidney, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 inclusion and 16 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 14 Apr 2015. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events (time frame: Daily). 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 14 Apr 2015.