Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
21 December 2021 |
Main ID: |
EUCTR2010-024381-21-IT |
Date of registration:
|
06/03/2012 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
A 12-month, multicenter, open label, randomized, controlled study to evaluate the efficacy, tolerability and safety of early introduction of everolimus, reduced CNI, and early steroid elimination compared to standard CNI, mycophenolate mofetil and steroid regimen in paediatric renal transplant recipients with a 24-month additional safety follow-up.
|
Scientific title:
|
A 12-month, multicenter, open label, randomized, controlled study to evaluate the efficacy, tolerability and safety of early introduction of everolimus, reduced CNI, and early steroid elimination compared to standard CNI, mycophenolate mofetil and steroid regimen in paediatric renal transplant recipients with a 24-month additional safety follow-up. |
Date of first enrolment:
|
03/10/2011 |
Target sample size:
|
106 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024381-21 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
Countries of recruitment
|
Argentina
|
Belgium
|
France
|
Germany
|
Hungary
|
Italy
|
Norway
|
Spain
|
Sweden
|
United Kingdom
|
United States
| | | | | |
Contacts
|
Name:
|
Drug Regulatory Affairs
|
Address:
|
Largo Umberto Boccioni, 1
21040
Origgio
Italy |
Telephone:
|
+39 02 96541 |
Email:
|
info.studiclinici@novartis.com |
Affiliation:
|
Novartis Farma |
|
Name:
|
Drug Regulatory Affairs
|
Address:
|
Largo Umberto Boccioni, 1
21040
Origgio
Italy |
Telephone:
|
+39 02 96541 |
Email:
|
info.studiclinici@novartis.com |
Affiliation:
|
Novartis Farma |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Inclusion criteria at baseline (transplantation) 1-Written informed consent/assent must be obtained from the parent(s) or legal guardian before any assessment is performed. 2- Primary paediatric kidney transplant greater than or equal to 1 year and younger than 18 years receiving a primary deceased donor or non- HLA identical living donor (related or unrelated) renal transplant. Inclusion criteria at randomization (4-6 weeks after transplantation) XML File Identifier: bfG7+TY4lV0RJvKqy+chzjhz4lE= Page 55/66 1-Patients on TAC + MMF + steroids. 2- Renal function with eGFR > 50 ml/min/1.73 m2 (Schwartz formula Are the trial subjects under 18? yes Number of subjects for this age range: 106 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: exclusion criteria at baseline: 1- Recipients of kidneys from donors with known renal disease (such as diabetes nephropathy, nephrosclerosis), at the time of transplant. 2 - Recipients of a kidney with a cold ischemia time > 24 hours. 3 - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. 4 - History of hypersensitivity or contraindications to any of the study drugs or to drugs of similar chemical classes, or to any of the excipients. 5 - History of malignancy of any organ system treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. other protocol-defined exclusion criteria may apply Exclusion criteria at Randomization (4-6 weeks after transplantation) 1 - Patients with ongoing or currently treated episodes of acute rejection (any grade) or a steroid resistant acute rejection at the time of randomization. 2 - Patients who experienced acute cellular rejection (Banff =1B) or any antibody mediated acute rejection or patients considered at high risk of antibody mediated acute rejection by the investigator assessment (e.g. presence of newly formed DSA, histological suspicion) at any time before randomization (as the DSA quantitative threshold to define high risk is not fully established, the assessment of the risk will be made after discussion between the laboratory expert and the investigator who will take into account all information available and apply best judgment). 3 - Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the investigator. 4 - Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and can not discontinue the treatment (see Appendix 6 for list of medications). 5 - Patients with nephrotic range proteinuria (protein to creatinine ratio =2.0 mg/mg or 200 mg/mmol. other protocol-defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Therapeutic area: Body processes [G] - Immune system processes [G12]
|
Prevention of acute rejection in paediatric recipients of a renal transplant MedDRA version: 14.1
Level: PT
Classification code 10038533
Term: Renal transplant
System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1
Level: LLT
Classification code 10023438
Term: Kidney transplant
System Organ Class: 10042613 - Surgical and medical procedures
|
Intervention(s)
|
Trade Name: CERTICAN*100CPR 0,25MG Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: Certican Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25-
Trade Name: CERTICAN*100CPR 0,5MG Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: Certican Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .5-
Trade Name: CERTICAN*100CPR 0,75MG Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: Certican Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .75-
Trade Name: CERTICAN*100CPR 1MG Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: Certican Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-
Trade Name: CERTICAN*100CPR DISPERS 0,1MG Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: Certican Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .1-
Trade Name: CERTICAN*100CPR DISPERS 0,25MG Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: Certican Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25-
Trade Name: PROGRAF*100CPS 0,5MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Concentration unit: mg milligram(s) Concen
|
Primary Outcome(s)
|
Secondary Objective: - To evaluate each of the components of the composite efficacy endpoint - To evaluate the time to event and severity of BPAR - To evaluate incidence of biopsy proven antibody mediated rejection - To Evaluate the incidence/progression of chronic allograft nephropathy (Interstitial Fibrosis and Tubular Atrophy IF/TA) by histopathology. - To evaluate growth and development, including linear growth, sexual maturation, hormonal gonadal axis (estradiol, testosterone, LH, FSH, inhibin B), TSH, T3 and T4
|
Main Objective: - To estimate the rate of the composite efficacy endpoint of BPAR, graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids. - - To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz formula (abbreviated) at month 12.
|
Primary end point(s): 1- The incidence of composite efficacy failure including BPAR, death, and graft loss at 12 months. Local biopsy readings will be used to determine the occurrence of BPAR. 2- Renal function will be assessed by eGFR estimated by the Schwartz formula (abbreviated) at month 12.
|
Timepoint(s) of evaluation of this end point: Month 12 after transplantation.
|
Secondary Outcome(s)
|
Secondary end point(s): 1- Components of the composite efficacy endpoint; 2- Incidences of biopsy proven antibody mediated rejection 3- Incidence/progression of chronic allograft nephropathy (interstitial fibrosis and tubular atrophy, IF/TA); 4- Safety (evolution of renal function over time, incidence of proteinuria, the frequency of drug-related side effects (CNI-related, mTOR-inhibitorspecific or MMF-class effects), assessment of growth and development, the frequency of AEs/Infections, SAEs.
|
Timepoint(s) of evaluation of this end point: Month 12 and 36 after transplantation.
|
Secondary ID(s)
|
2010-024381-21-HU
|
CRAD001A2314
|
Source(s) of Monetary Support
|
Novartis Pharma
|
Ethics review
|
Status: Approved
Approval date: 20/07/2011
Contact:
|
|