pediatric de novo renal trasplant MedDRA version: 7.0 Level: LLT Classification code 10050432
Conditions
Interventions
Trade Name: Certican 0.1mg fast-dispersable tablets
Product Name: Certican
Product Code: RAD001B
Pharmaceutical Form: Dispersible tablet
Concentration unit: mg milligram(s)
Concentration type: up to
C
Sponsors
Novartis Farmaceútica S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a.Male and female patients ? 16 years of age. b.Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant. c.The graft must be functional within 48 hours post transplantation. A functional graft is defined at the investigator’s determination by a 50 % fall of serum creatinine from the pre-transplant value. In the event of dialysis immediately preceding transplantation, the pre-dialysis serum creatinine value may be used. d.Females capable of becoming pregnant must have a negative pregnancy test (qualitative dip stick test on urine) immediately prior to study entry. Females of child bearing potential must practice an approved method of birth control for the one year duration of the study and for a period of three months following discontinuation of study medication. e.Patients who are willing and able to participate in the whole course of the study and for whom written informed consent has been obtained from the parent(s) or legal guardian. Are the trial subjects under 18? yes Number of subjects for this age range: 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: a.Cold ischemia time > 40 hours. b.Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs. c.Patients with non-diarrhea associated hemolytic-uremic syndrome. d.Recipients of donor specific transfusions. e.Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation. f.Patients unable to undergo renal biopsies post-transplant. g.Induction therapy with ALG, ATG and OKT3. h.Use of anti-fungal azoles such as ketoconazole, itraconazole and fluconazole. i.Patients requiring treatments with rifampin, carbamazepine, phenobarbital, phenytoin at the time of entry in the study. j.The use of any investigational drug within 4 weeks prior to administration of the initial dose of study medication. k.Patients who have received an investigational immunosuppressive agent within 4 months prior to administration of the initial dose of study medication. l.Presence of any severe allergy (within 4 weeks prior to administration of the initial dose of study medication) requiring acute or chronic treatment; or hypersensitivity to drugs similar to RAD001 (e.g., erythromycin or other macrolide antibiotics) or to any component of the formulation. m.Patients with any known contraindication to CsA. n.Patients with severe or unstable medical conditions likely to affect patient safety or the objectives of this study. Other social circumstances that prevent full compliance with the protocol. o.Patients with a history of alcohol or drug abuse, or signs of alcohol-induced organ damage, mental dysfunction or other factors limiting their ability to cooperate fully with the study. p.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following: presence of inflammatory bowel syndrome, or gastrointestinal bleeding; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (bladder augmentations and feeding tubes are acceptable). q.Patients who are Hepatitis C positive, HIV positive, or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to administration of the initial dose of study medication are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen, Hepatitis C or HIV. r.Evidence of liver injury as indicated by abnormal liver tests (AST or ALT > 3 times ULN, total bilirubin > 2 mg/dL). s.Presence of uncontrolled hypercholesterolemia ( =350 mg/dL, = 9.1 mmol/L) or hypertriglyceridemia (= 500 mg/dL, = 5.6 mmol/L). t.White blood cell count = 4500/mm3 or platelet count = 100,000/mm3. u.Patients with severe systemic infections. v.Patients with any past or present malignancy (other than excised basal cell carcinoma). w.History of splenectomy. x.Patients with any history of significant coagulopathy or medical condition requiring long term systemic anticoagulation after transplantation which would interfere with obtaining biopsies. Low dose aspirin is allowed. y.Abnormal physical or laboratory findings of clinical significance which would interfere with the objectives of the study. z.Females who are breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the safety and tolerability of RAD001 administered b.i.d. in combination with Neoral® and corticosteroids in pediatric de novo renal transplant recipients, and to provide additional safety data (quantitative protein/creatinine ratio in urine).;Secondary Objective: 1.To evaluate the efficacy of RAD001 administered b.i.d. in combination with Neoral® and corticosteroids as measured by the incidence of biopsy proven acute allograft rejection episodes, graft loss or death at 6 and 12 months after initial dose of study medication. 2.To characterize the multiple dose pharmacokinetics of RAD001 administered b.i.d. 3.To evaluate the efficacy of RAD001 administered b.i.d. in combination with Neoral® and corticosteroids in the prevention of chronic allograft rejection (chronic graft dysfunction) at 12 months post-transplantation. ;Primary end point(s): To evaluate the safety and tolerability of RAD001 administered b.i.d. in combination with Neoral® and corticosteroids in pediatric de novo renal transplant recipients | — |
Countries
Spain
Outcome results
None listed