Type 1 Diabetes MellitusPhase 1/2NCT00692562
Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease
A Phase 1/2 study testing simultaneous islet-kidney transplantation in people with Type 1 Diabetes Mellitus and End-stage Renal Disease, run by Fuzhou General Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, End-stage Renal Disease
- What is being tested?
- simultaneous islet-kidney transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- Jun 2005to Dec 2007
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients age 18 to 60 years of age.
- Ability to provide written informed consent.
- Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(1999) on the Diagnosis and classification of Diabetes Mellitus.
- manifest signs and symptoms that are severe enough to be incapacitating.
- Basal C-peptide<0.5ng/mL
- patients with poor diabetes control (HbA1c >7% but <12%)
- progressive diabetic complications.
- end-stage renal disease(serum creatinine>450μmol/l)
Who cannot join
- age <18 years or >60 years
- diabetic history <5 years
- BMI>27
- body weight >80kg
- exogenous insulin requirement >1 unit/kg/day
- severe anemia (male <8g/dl, female <7g/dl)
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- low white blood cell count (<3000/dl)
- liver dysfunction
- Symptomatic peptic ulcer disease
- Any malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB
- panel reactive antibody >20%
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab treatment.
- Conditions
- Type 1 Diabetes Mellitus, End-stage Renal Disease
- Being tested
- simultaneous islet-kidney transplantation
- Keywords
- Islets of Langerhans Transplantation, Kidney Transplantation, Type 1 Diabetes Mellitus, alemtuzumab
- Medical subject headings
- Diabetes Mellitus, Type 1, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous islet-kidney transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: simultaneous islet-kidney transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exogenous insulin requirement
Measured: 5
kidney function
Measured: 5
Secondary outcomes (6)
Hemoglobin A1c
Measured: 5
Glucose and C-peptide levels
Measured: 5
Portal vein Ultrasound
Measured: 1
liver function
Measured: 5
Complete Blood Count
Measured: 5
autoantibodies
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2005
- Primary completionDec 2006
- Study completionDec 2007
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 Type 1 Diabetes MellitusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jianming Tan, professor, Principal investigator, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692562
- Sponsor's protocol ID
- SIK2005
- Status last verified
- Jun 2008
- First submitted
- 3 Jun 2008
- Last updated
- 16 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tan J, Yang S, Cai J, Guo J, Huang L, Wu Z, Chen J, Liao L. Simultaneous islet and kidney transplantation in seven patients with type 1 diabetes and end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Diabetes. 2008 Oct;57(10):2666-71. doi: 10.2337/db08-0358. Epub 2008 Jul 15.
PubMed 18633105
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT00692562
- Acronym / sponsor ID
- SIK2005
- Conditions
- Type 1 Diabetes Mellitus, End-stage Renal Disease
- Keywords
- Islets of Langerhans Transplantation, Kidney Transplantation, Type 1 Diabetes Mellitus, alemtuzumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Jun 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.
The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: simultaneous islet-kidney transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female patients age 18 to 60 years of age.
- Ability to provide written informed consent.
- Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(1999) on the Diagnosis and classification of Diabetes Mellitus.
- manifest signs and symptoms that are severe enough to be incapacitating.
- Basal C-peptide<0.5ng/mL
Key exclusion criteria (13 listed)
- age <18 years or >60 years
- diabetic history <5 years
- BMI>27
- body weight >80kg
- exogenous insulin requirement >1 unit/kg/day
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 |
|---|---|---|
| simultaneous islet-kidney transplantation | Procedure or surgery | A |
Primary outcome
Exogenous insulin requirement
Time frame: 5
kidney function
Time frame: 5
6 secondary outcomes
Hemoglobin A1c
Time frame: 5
Glucose and C-peptide levels
Time frame: 5
Portal vein Ultrasound
Time frame: 1
liver function
Time frame: 5
Complete Blood Count
Time frame: 5
autoantibodies
Time frame: 5
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 16 Sep 2011.
- Derived from this study: PubMed 18633105Tan J, Yang S, Cai J, Guo J, Huang L, Wu Z, Chen J, Liao L. Simultaneous islet and kidney transplantation in seven patients with type 1 diabetes and end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Diabetes. 2008 Oct;57(10):2666-71. doi: 10.2337/db08-0358. Epub 2008 Jul 15.
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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.
Jianming Tan, professor principal investigator
Fuzhou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing simultaneous islet-kidney transplantation in people with Type 1 Diabetes Mellitus and End-stage Renal Disease, run by Fuzhou General Hospital at 1 site in China.
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 8 inclusion and 13 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 16 Sep 2011. 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Exogenous insulin requirement (time frame: 5). The study lists 2 primary outcomes in all. 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 NCT00692562, 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 16 Sep 2011.