Renal Transplant PatientsPhase 3ATGNCT00733733
Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor
A Phase 3 study testing ATG Fresenius in people with Renal Transplant Patients and Recipients of a Kidney From a Non-Heart-Beating Donor, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
One of the greatest problems in renal transplantation is the shortage of donor kidneys. Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Patients, Recipients of a Kidney From a Non-Heart-Beating Donor
- What is being tested?
- ATG Fresenius
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-heart-beating-donors (Maastricht III/IV)
- Female patients of childbearing age agree to maintain effective birth control practice during the study.
Who cannot join
- Pregnant or lactating women at the time of randomization.
- Patients and donors are ABO incompatible.
- Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
- Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
- Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant.
- Patients, who are HIV positive.
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- Patients subjected to previous transplants or candidates for multiple transplants (e.g. SKP).
- Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator.
- Patients with pulmonary oedema or with other signs of overhydration.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC St Radboud Hospital
Nijmegen, 6525 GA
andries hoitsma, prof. dr., +31243614761, a.hoitsma@nier.umcn.nl
Luuk Hilbrands, Dr., +31243614761, l.hilbrands@nier.umcn.nl
About this study
Official title: A Prospective, Randomized, Open, Multicenter Study to Evaluate the Efficacy and Tolerability of Induction Therapy With a Single High-Dose Anti-T-Lymphocyte Globulin (ATG) in Renal Transplant Patients With a Kidney From a Non-Heart-Beating Donor and Tacrolimus, Mycophenolate Mofetil, and Steroids as Basic Immunosuppression.
One of the greatest problems in renal transplantation is the shortage of donor kidneys. Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion injury. The increased ischemia-reperfusion injury results in an increased immune activation, which can lead to more injury of the kidney and additional acute rejections. The hypothesis of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have additional favourable effects. To investigate this half of the patients is treated with additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not diminished during the first days after transplantation to investigate whether ATG has special effects on ischemia-reperfusion injury.
- Being tested
- ATG Fresenius
- Keywords
- kidney, transplantation, non-heart-beating donor, delayed graft function, Antithymocyte globulin, ischemia-reperfusion damage
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG FreseniusDrug
One gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone)
| Study group | Role | What they receive |
|---|---|---|
| ATG | Active comparator | One gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone) Receives: Drug: ATG Fresenius |
| Control | No intervention | Standard immunosuppressive treatment for renal transplantation including tacrolimus/MMF/prednisolone without ATG treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of initial delayed graft function (defined as need for dialysis)
Measured: Within three months after transplantation
Secondary outcomes (14)
Duration of initial delayed graft failure
Measured: Within 3 months after transplantation
Incidence of primary never-functioning grafts
Measured: Within 3 months after transplantation
Incidence of acute rejections (biopsy proven)
Measured: Within 3 months after transplantation
Renal function as determined by MDRD
Measured: At 1, 2, 3 months after transplantation
Proteinuria
Measured: At 1, 2, 3 months after transplantation
Percentage of patients with arterial hypertension
Measured: At 3 months after transplantation
Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs)
Measured: At 3 months after transplantation
Percentage of hyperlipidemic patients
Measured: At 3 months after transplantation
Percentage of post transplant diabetes mellitus
Measured: During 3 months after transplantation
Incidence of cytomegalovirus infection
Measured: During 3 months after transplantation
Incidence of tumours/PTLD
Measured: At 3 months after transplantation
Patient and graft survival
Measured: At 3 months after transplantation
Incidence of other infections
Measured: During 3 months after transplantation
Microalbuminuria
Measured: At 1, 2, 3 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 posted13 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant PatientsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Maastricht University, Leiden University Medical Center, UMC Utrecht, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- andries hoitsma, prof.dr., Principal investigator, UMC St Radboud Hospital, Nijmegen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733733
- Sponsor's protocol ID
- Euro-NHB
- Acronym
- ATG
- Status last verified
- Aug 2008
- First submitted
- 12 Aug 2008
- Last updated
- 13 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open, Multicenter Study to Evaluate the Efficacy and Tolerability of Induction Therapy With a Single High-Dose Anti-T-Lymphocyte Globulin (ATG) in Renal Transplant Patients With a Kidney From a Non-Heart-Beating Donor and Tacrolimus, Mycophenolate Mofetil, and Steroids as Basic Immunosuppression.
- ClinicalTrials.gov ID
- NCT00733733
- Acronym / sponsor ID
- ATG / Euro-NHB
- Keywords
- kidney, transplantation, non-heart-beating donor, delayed graft function, Antithymocyte globulin, ischemia-reperfusion damage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Maastricht University, Leiden University Medical Center, UMC Utrecht, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 13 Aug 2008 (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.
One of the greatest problems in renal transplantation is the shortage of donor kidneys. Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion injury. The increased ischemia-reperfusion injury results in an increased immune activation, which can lead to more injury of the kidney and additional acute rejections. The hypothesis of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have additional favourable effects. To investigate this half of the patients is treated with additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not diminished during the first days after transplantation to investigate whether ATG has special effects on ischemia-reperfusion injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG | Active comparator | Drug: ATG FreseniusOne gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone) |
| Control | No intervention | –Standard immunosuppressive treatment for renal transplantation including tacrolimus/MMF/prednisolone without ATG treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-heart-beating-donors (Maastricht III/IV)
- Female patients of childbearing age agree to maintain effective birth control practice during the study.
Key exclusion criteria (9 listed)
- Pregnant or lactating women at the time of randomization.
- Patients and donors are ABO incompatible.
- Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
- Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
- Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant.
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 FreseniusOne gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone) | Drug | ATG |
Primary outcome
Incidence of initial delayed graft function (defined as need for dialysis)
Time frame: Within three months after transplantation
14 secondary outcomes
Duration of initial delayed graft failure
Time frame: Within 3 months after transplantation
Incidence of primary never-functioning grafts
Time frame: Within 3 months after transplantation
Incidence of acute rejections (biopsy proven)
Time frame: Within 3 months after transplantation
Renal function as determined by MDRD
Time frame: At 1, 2, 3 months after transplantation
Proteinuria
Time frame: At 1, 2, 3 months after transplantation
Percentage of patients with arterial hypertension
Time frame: At 3 months after transplantation
Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs)
Time frame: At 3 months after transplantation
Percentage of hyperlipidemic patients
Time frame: At 3 months after transplantation
Percentage of post transplant diabetes mellitus
Time frame: During 3 months after transplantation
Incidence of cytomegalovirus infection
Time frame: During 3 months after transplantation
Incidence of tumours/PTLD
Time frame: At 3 months after transplantation
Patient and graft survival
Time frame: At 3 months after transplantation
Incidence of other infections
Time frame: During 3 months after transplantation
Microalbuminuria
Time frame: At 1, 2, 3 months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2008.
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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.
andries hoitsma, prof.dr. principal investigator
UMC St Radboud Hospital, Nijmegen, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ATG Fresenius in people with Renal Transplant Patients and Recipients of a Kidney From a Non-Heart-Beating Donor, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Aug 2008. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andries Hoitsma, Prof. Dr. (+31243614761, a.hoitsma@nier.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of initial delayed graft function (defined as need for dialysis) (time frame: Within three months after transplantation). 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 13 Aug 2008.