Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
120
Countries
1
Sites
1
End-stage kidney disease in Type 1 diabetes
To compare the incidence of incisional hernia following combined pancreas and kidney transplantation in type 1 diabetic subjects with end-stage kidney disease treated with to different immunosuppressive rengimens
Key facts
- Sponsor
- Institute For Clinical And Experimental Medicine
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 9 Sep 2020 → ongoing
- Decision date (initial)
- 2024-10-08
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Institute for Clinical and Experimental Medicine · Ministry of Health of the Czech Republic, Czech Health Research Council
External identifiers
- EU CT number
- 2024-517391-38-00
- EudraCT number
- 2019-002240-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
To compare the incidence of incisional hernia following combined pancreas and kidney transplantation in type 1 diabetic subjects with end-stage kidney disease treated with to different immunosuppressive rengimens
Secondary objectives 2
- Comparisson of the course of advanced microvascular complication of diabetes following combined pancreas and kidney transplantation in type 1 diabetic recipients treated either with mycophenolate mofetil or sirolimus as components of prophylactic immunosuppressive therapy
- To compare the efficacy of sirolimus and mycophenolate mofetil in type 1 diabetic recipients of pancreas and kidney as components of tacrolimus based immunosuppressive regimens
Conditions and MedDRA coding
End-stage kidney disease in Type 1 diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10074474 | Transplantation complications | 10022117 |
Regulatory references
- Scientific advice from competent authorities
- Institute For Clinical And Experimental Medicine
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 1 Male or female patients, of 18 to 65 years of age, with a pre- or an end-stage renal failure, Type 1-diabetic nephropathy
- Patient is scheduled to be put on waiting-list for a primary simultaneous pancreas/kidney (SPK) cadaver transplant
Exclusion criteria 10
- Patient is pregnant or breastfeeding
- Patient is allergic or intolerant to any drug comprising both immunosuppressive protocols
- Patient has a positive T-cell cross-match 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 localized squamous cell or basal cell carcinoma, without recurrence.
- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication
- Patient receives a kidney transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone
- Donor is older than 65 years of age
- Patient has a high immunological risk, defined as a PRA grade > 50%
- Patient has a history of an extensive abdominal operation or a hernia in the abdominal wall
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- A new occurrence of an incisional hernia that is closely related to the transplantation procedure
Secondary endpoints 8
- A new occurrence of hernia in other localizations without relation to SPK surgery
- A new occurrence of a lymphocele or other surgical complications (ureteral leak, bleeding, infection) whenever after transplantation
- Patient and graft survival rates
- Rejection rate (kidney, pancreas or both). A kidney or pancreas biopsy will be taken as clinically indicated in case of suspected rejection of either kidney or pancreas. Biopsy analysis will be done according to latest BANFF 2017 criteria
- Treatment intolerance (permanent mycophenolate mofetil or sirolimus withdrawal for more than 40 days
- Blood glucose and C-peptide levels (AUC) following a mixed meal test, average levels; blood glucose variability assessed a standard error of glucose levels registered using continuous glucose monitoring (CGM) with a subcutaneous glucose sensor
- Creatinine clearance rate calculated by the CKD-EPI formula and glycosylated hemoglobin values
- Progression of diabetic microangiopathic complication (retinopathy, neuropathy)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD3342088 · Product
- Active substance
- Sirolimus
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 3000000 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA10 — SIROLIMUS
- Marketing authorisation
- EU/1/01/171/007
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institute For Clinical And Experimental Medicine
- Sponsor organisation
- Institute For Clinical And Experimental Medicine
- Address
- Videnska 1958/9 Krc
- City
- Prague
- Postcode
- 140 00
- Country
- Czechia
Scientific contact point
- Organisation
- Institute For Clinical And Experimental Medicine
- Contact name
- Jitka Zavřelová
Public contact point
- Organisation
- Institute For Clinical And Experimental Medicine
- Contact name
- Jitka Zavřelová
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2020-09-09 | 2020-09-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Studie SIMA - SPK Study protocol-finalni verze | 1 |
| Recruitment arrangements (for publication) | Subject recruitment strategy study EUDRACT 2019_002240_24 | 1 |
| Subject information and informed consent form (for publication) | Informovany souhlas studie SIMA SPK-finalni verze | 1 |
| Synopsis of the protocol (for publication) | Study sympsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-10 | Czechia | Acceptable with conditions 2024-10-08
|
2024-10-08 |