Renal TransplantationPhase 1NCT00223067
Induction of Donor-Specific Tolerance in Renal Allograft Recipients (Living Donor) With TAIZ-Monocytes
A Phase 1 study testing TAIZ in people with Renal Transplantation, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
reduce of immunsupression or introduce tolerance with so called TAIZ-monocytes in renal transplant patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- TAIZ
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to May 2006
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following inclusion criteria to be considered for admission to the trial:
- Male or female adult patients aged between 18 and 64 years (inclusive). A female of childbearing potential may be enrolled provided she:
- has a negative pregnancy test at Screening and
- is routinely using adequate contraception prior to and during the study and
- agrees not to attempt to become pregnant during the study and
- is not lactating A female of non-childbearing potential will be defined as one who has been postmenopausal for at least one year or has been surgically sterilised.
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- Patients receiving a first renal transplant.
- Patients who fulfil the criteria to receive an allogenic renal transplant (according to the Eurotransplant (ET) manual on organ allocation and the Bundesärztekammer allocation criteria) and who are listed on a waiting list.
- Patients who, after the nature of the study and the disclosure of their data has been explained to them, have freely given Informed Consent in writing.
- In vitro demonstration of the suppressive effect of the donor TAIC for the donor-recipient pair.
Who cannot join
- Patients presenting any of the following exclusion criteria must not be included in the trial:
- Patients who have received a renal transplant.
- Patients who have an active infection at the time of entry into the study (Screening).
- Recipient and donor pairs who show the following incompatible EBV or CMV constellation: the donor is EBV or CMV positive and the recipient is EBV or CMV negative.
- Patients and/or donors who have positive evidence of HIV or have active virus hepatitis B and C.
- Patients with a history of alcohol and/or drug abuse or sepsis.
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- Patients who are pregnant women or nursing mothers.
- Known hypersensitivity or contraindication to one of the immunosuppressives administered during the course of the study: ATG, tacrolimus, or steroids (prednisolone).
- Patients with a history or present symptoms of autoimmune vasculitis.
- Detection of > 5% HLA antibodies (all current and historic values).
- Patients with a malignancy or history of malignancy.
- Patients with renal insufficiency due to a vasculitis.
- Patients whose condition requires continuous systemic administration of immunosuppressives.
- Missing immunosuppressive effect of the donor TAIC for the donor-recipient pair in vitro test.
- Patients who are simultaneously participating or plan to participate in any other clinical study.
- Psychiatric or emotional problems or lack of knowledge of the German language which would invalidate the giving of Informed Consent or limit the ability of the subject to comply with study requirements.
- Unwillingness or inability to provide Informed Consent or to participate satisfactorily for the entire trial period
- Patients with corresponding donors presenting any one of the exclusion criteria documented in the Eurotransplant guidelines ( ) must not be included in the trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Kiel, 24105
Ulrich Kunzendorf, MD, 004315971338, Kunzendorf@nephro.uni-kiel.de
Lutz Renders, MD
About this study
Official title: A Multi-Center Open-Labeled Study of the Administration of Allogenic and Autologous Regulatory Cells for the Induction of Donor-Specific Tolerance in Renal Allograft Recipients (Living Donor)
reduce of immunsupression or introduce tolerance with so called TAIZ-monocytes in renal transplant patients
- Conditions
- Renal Transplantation
- Being tested
- TAIZ
- Keywords
- renal transplantation, TAIZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAIZDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
graft survival and reduction or withdrawal of immunosuppressives after treatment with Transplant-Acceptance Inducing Cells (TAIC) and autologous regulatory T cells (tregs)
serum creatinine
rejection episodes
necessity for re-introduction of any immunosuppressives.
Secondary outcomes (1)
safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) in terms of rejection episodes and Adverse Events (AEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich Kunzendorf, MD, Principal investigator, University of Schleswig-Holstein, Campus Kiel Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223067
- Sponsor's protocol ID
- 005
- Status last verified
- Apr 2004
- First submitted
- 14 Sep 2005
- Last updated
- 28 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Open-Labeled Study of the Administration of Allogenic and Autologous Regulatory Cells for the Induction of Donor-Specific Tolerance in Renal Allograft Recipients (Living Donor)
- ClinicalTrials.gov ID
- NCT00223067
- Acronym / sponsor ID
- 005
- Conditions
- Renal Transplantation
- Keywords
- renal transplantation, TAIZ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- May 2006
- First posted
- 22 Sep 2005 (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.
reduce of immunsupression or introduce tolerance with so called TAIZ-monocytes in renal transplant patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must meet all the following inclusion criteria to be considered for admission to the trial:
- Male or female adult patients aged between 18 and 64 years (inclusive). A female of childbearing potential may be enrolled provided she:
- Patients receiving a first renal transplant.
- Patients who fulfil the criteria to receive an allogenic renal transplant (according to the Eurotransplant (ET) manual on organ allocation and the Bundesärztekammer allocation criteria) and who are listed on a waiting list.
- Patients who, after the nature of the study and the disclosure of their data has been explained to them, have freely given Informed Consent in writing.
Key exclusion criteria (18 listed)
- Patients presenting any of the following exclusion criteria must not be included in the trial:
- Patients who have received a renal transplant.
- Patients who have an active infection at the time of entry into the study (Screening).
- Recipient and donor pairs who show the following incompatible EBV or CMV constellation: the donor is EBV or CMV positive and the recipient is EBV or CMV negative.
- Patients and/or donors who have positive evidence of HIV or have active virus hepatitis B and C.
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 |
|---|---|---|
| TAIZ | Drug | – |
Primary outcome
graft survival and reduction or withdrawal of immunosuppressives after treatment with Transplant-Acceptance Inducing Cells (TAIC) and autologous regulatory T cells (tregs)
serum creatinine
rejection episodes
necessity for re-introduction of any immunosuppressives.
1 secondary outcome
safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) in terms of rejection episodes and Adverse Events (AEs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2005.
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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.
Ulrich Kunzendorf, MD principal investigator
University of Schleswig-Holstein, Campus Kiel Department of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAIZ in people with Renal Transplantation, run by University Hospital Schleswig-Holstein 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 10 inclusion and 18 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 28 Oct 2005. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ulrich Kunzendorf (004315971338, kunzendorf@nephro.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft survival and reduction or withdrawal of immunosuppressives after treatment with Transplant-Acceptance Inducing Cells (TAIC) and autologous regulatory T cells (tregs). The study lists 4 primary outcomes in all. 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 28 Oct 2005.