Diabetes Mellitus, Type 1Phase 3NCT00140543
European Trial of Immunosuppression in SPK Tx
A Phase 3 study testing sirolimus versus mycophenolate mofetil in people with Diabetes Mellitus, Type 1 and Diabetic Nephropathy, run by EUROSPK Study Group at 14 sites in 7 countries.
Trial summary
1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation. 2. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetic Nephropathy
- What is being tested?
- sirolimus versus mycophenolate mofetil
- How many people
- 228 participants
- Where
- 14 sitesin 7 countries
- Study dates
- Feb 2002to 30 Sep 2005
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
- Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
- Patient must have signed the Patient Informed Consent Form.
- Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
Who cannot join
- Patient is pregnant or breastfeeding.
- Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
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- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
- Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
- Pancreatic duct occlusion technique .
- Donor is older than 55 years of age.
- -
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Germany6 sites
Charite Campus Virchow Klinikum
Berlin, 13353
Goethe University
Frankfurt am Main, 60590
Chirurgische Universitätsklinik
Freiburg im Breisgau, 79111
Knappschaftskrankenhaus
Langendreer, 44892
Klinikum Grosshadern-University of Munich
Munich, 81366
Klinikum Innenstadt der Universität München
Munich, 90336
Belgium3 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
UZ Gent
Ghent, 9000
UZ Gasthuisberg
Leuven, 3000
Czechia1 site
Institute for clinical and experimental medicine-IKEM
Prague, 14021
About this study
Official title: A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy, Short-Term Steroids Application in de Novo SPK Transplanted Diabetic Patients
- To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation.
- To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.
Read the detailed description
This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Nephropathy
- Being tested
- sirolimus versus mycophenolate mofetil
- Keywords
- simultaneous pancreas/kidney transplantation, Immunosuppression
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus versus mycophenolate mofetilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.
Secondary outcomes (18)
SECONDARY ENDPOINTS: At 6 months and 1 year
* Kidney/Pancreas function (at 6 months and 1 year):
- Kidney function will be measured by:
- S- creatinine
- Creatinine clearance
- Pancreas function will be measured by:
- Fasting Glucose level (< 123 mg/dl)
- HbA1C
- Need for insulin therapy
- Need for oral drugs
* At 6 months and 1 year:
- Patient and graft survival
- Lipid profile
- Infections
- Side effects
- Blood Pressure
- Treatment failure for any reason, such as permanent discontinuation of a drug, graft loss or death.
* % of steroid free patients: at 6 months and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startFeb 2002
- Study completion30 Sep 2005
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 Diabetes Mellitus, Type 1Studies 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
- 228 participants
Sponsor and investigators
- Lead sponsor
- EUROSPK Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Fujisawa GmbH, Hoffmann-La Roche, Wyeth is now a wholly owned subsidiary of Pfizer, Neovii Biotech, Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Squifflet, MD,PhD, Study chair, SPEAKER FOR THE EUROSPK STUDY GROUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140543
- Sponsor's protocol ID
- EUROSPK002
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2005
- Last updated
- 23 Aug 2021
- Results posted
- No
Publications
Pisova B, Chytilova S, Saudek F, Girman P. Sirolimus Versus Mycophenolate Mofetil in Simultaneous Pancreas-Kidney Transplantation: Impact on Urinary Tract Infection Rates. J Transplant. 2026 Apr 1;2026:6985179. doi: 10.1155/joot/6985179. eCollection 2026.
PubMed 41929991
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy, Short-Term Steroids Application in de Novo SPK Transplanted Diabetic Patients
- ClinicalTrials.gov ID
- NCT00140543
- Acronym / sponsor ID
- EUROSPK002
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Nephropathy
- Keywords
- simultaneous pancreas/kidney transplantation, Immunosuppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants
- Lead sponsor
- EUROSPK Study GroupUniversity, hospital or other
- Collaborators
- Fujisawa GmbH, Hoffmann-La Roche, Wyeth is now a wholly owned subsidiary of Pfizer, Neovii Biotech, Genzyme, a Sanofi Company
- Study start
- Feb 2002
- Study completion
- 30 Sep 2005 (actual)
- First posted
- 1 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.
- To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation.
- To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.
Detailed description
This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
- Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
- Patient must have signed the Patient Informed Consent Form.
- Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
Key exclusion criteria (11 listed)
- Patient is pregnant or breastfeeding.
- Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
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 |
|---|---|---|
| sirolimus versus mycophenolate mofetil | Drug | – |
Primary outcome
At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.
18 secondary outcomes
SECONDARY ENDPOINTS: At 6 months and 1 year
* Kidney/Pancreas function (at 6 months and 1 year):
- Kidney function will be measured by:
- S- creatinine
- Creatinine clearance
- Pancreas function will be measured by:
- Fasting Glucose level (< 123 mg/dl)
- HbA1C
- Need for insulin therapy
- Need for oral drugs
* At 6 months and 1 year:
- Patient and graft survival
- Lipid profile
- Infections
- Side effects
- Blood Pressure
- Treatment failure for any reason, such as permanent discontinuation of a drug, graft loss or death.
* % of steroid free patients: at 6 months and 1 year.
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 23 Aug 2021.
- Derived from this study: PubMed 41929991Pisova B, Chytilova S, Saudek F, Girman P. Sirolimus Versus Mycophenolate Mofetil in Simultaneous Pancreas-Kidney Transplantation: Impact on Urinary Tract Infection Rates. J Transplant. 2026 Apr 1;2026:6985179. doi: 10.1155/joot/6985179. eCollection 2026.
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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.
Jean-Paul Squifflet, MD,PhD study chair
SPEAKER FOR THE EUROSPK STUDY GROUP
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sirolimus versus mycophenolate mofetil in people with Diabetes Mellitus, Type 1 and Diabetic Nephropathy, run by EUROSPK Study Group at 14 sites in 7 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 4 inclusion and 11 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Belgium, Austria, Czechia, Israel and 2 more countries. 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 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?
At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140543, 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 23 Aug 2021.