Islet TransplantationNCT00409461
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
A study testing ATG-Sirolimus-Tacrolimus in people with Islet Transplantation and Type 1 Diabetes, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial summary
Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Islet Transplantation, Type 1 Diabetes
- What is being tested?
- ATG-Sirolimus-Tacrolimus
- How many people
- Not given
- Where
- 2 sitesBelgium
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Adult, Older adult
Who may be able to join
- Type 1 insulin-dependent diabetic patients
- C-peptide < 0.15 nmol/l (<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
- diabetic nephropathy
- hypoglycaemic unawareness
Who cannot join
- smoker before transplantation
- plasma creatinine > 2 mg/dl
- albuminuria >1000 mg/24 hrs
- abnormal liver function
- history of thrombosis or pulmonary embolism
- history of malignancy, tuberculosis or chronic viral hepatitis
Show all 10Show fewer
- history of any other serious illness which could be relevant for the protocol
- HLA antibodies
- EBV antibody negative
- HIV 1 \& 2 antibody positive
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Brussels, 1090
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Leuven, 3000
About this study
Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients
- Conditions
- Islet Transplantation, Type 1 Diabetes
- Being tested
- ATG-Sirolimus-Tacrolimus
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-Sirolimus-TacrolimusDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Islet TransplantationStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Belgian Government
- Investigators
- Bart Keymeulen, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409461
- Sponsor's protocol ID
- 4-2001-434
- Other IDs
- G.0375.00, G.0084.02, GOA/2004/10
- Status last verified
- Dec 2006
- First submitted
- 8 Dec 2006
- Last updated
- 11 Dec 2006
- Results posted
- No
Publications
Gillard P, Ling Z, Mathieu C, Crenier L, Lannoo M, Maes B, Roep B, Gorus F, Pipeleers D, Keymeulen B. Comparison of sirolimus alone with sirolimus plus tacrolimus in type 1 diabetic recipients of cultured islet cell grafts. Transplantation. 2008 Jan 27;85(2):256-63. doi: 10.1097/TP.0b013e31815e8926.
PubMed 18212631
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
- ClinicalTrials.gov ID
- NCT00409461
- Acronym / sponsor ID
- 4-2001-434
- Conditions
- Islet Transplantation, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Belgian Government
- First posted
- 11 Dec 2006 (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.
Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 insulin-dependent diabetic patients
- C-peptide < 0.15 nmol/l (<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
- diabetic nephropathy
- hypoglycaemic unawareness
Key exclusion criteria (10 listed)
- smoker before transplantation
- plasma creatinine > 2 mg/dl
- albuminuria >1000 mg/24 hrs
- abnormal liver function
- history of thrombosis or pulmonary embolism
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-Sirolimus-Tacrolimus | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2006.
- Derived from this study: PubMed 18212631Gillard P, Ling Z, Mathieu C, Crenier L, Lannoo M, Maes B, Roep B, Gorus F, Pipeleers D, Keymeulen B. Comparison of sirolimus alone with sirolimus plus tacrolimus in type 1 diabetic recipients of cultured islet cell grafts. Transplantation. 2008 Jan 27;85(2):256-63. doi: 10.1097/TP.0b013e31815e8926.
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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.
Bart Keymeulen, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATG-Sirolimus-Tacrolimus in people with Islet Transplantation and Type 1 Diabetes, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
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 4 inclusion and 10 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 11 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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.
Are results available for this study?
The study was stopped early. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00409461, which also lists 1 linked publication.
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 11 Dec 2006.