PATIENTS WITH RENAL TRANSPLANT AND CHRONIC RENAL FAILURE MedDRA version: 9.1 Level: SOC Classification code 10038359
Conditions
Interventions
Trade Name: ARANESP
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 years or older • Renal transplant > 6 months prior to randomization • Haemoglobin concentration between 11.5 and 12.5 g/dl at Baseline (mean of the two values obtained at week -4 and -2 during screening period)obtained with darbepoetin in the group A (group darbepoetin) and without any eritropoietin in the group B (group untreated) • No ESA therapy during the 3 months prior to randomization • Adequate iron status (serum ferritin =100 ng/mL as well as TSAT =20% or hypochromic red cells =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Requirement for haemodialysis or peritoneal dialysis therapy within 3 months prior to randomization ? mTOR inhibitors (Sirolimus, Everolimus) based Immunosuppression • Change in haemoglobin concentration = 1.5 g/dL during the screening period (week -4 and -2) • Change in GFR >30% during the screening period • Treatment for clinical acute rejection during screening period with GFR stability below 30% • Recipients of other solid organs in addition to kidney • Patients planned to be switched from one immunosuppressive agent to another during study participation • History of positive Anti-phospholipid antibodies • Transfusion of red blood cells during the 3 months prior to randomization • Poorly controlled hypertension as judged by the investigator, or requiring more than 3 antihypertensive drugs (excluding diuretics) • Significant acute or chronic bleeding, such as overt gastrointestinal bleeding, i.e. requiring therapy within 3 months prior to randomization • Active malignant disease (except non-melanoma skin cancer) • Haemolysis • Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) • Folic acid deficiency • Vitamin B12 deficiency • Platelet count >500 x 109/L or <100 x 109/L • Pure red cell aplasia • Epileptic seizure in the 6 months prior to randomization • Congestive heart failure (NYHA Class IV) • Myelofibrosis • Active systemic lupus erythematosus • Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during 3 months prior to randomization • Uncontrolled or symptomatic secondary hyperparathyroidism • Women with positive pregnancy tests prior to randomization • Women of childbearing potential without effective contraception or women in lactation period • Participation in a clinical trial or receipt of investigational compound or treatment within the 3 months prior to randomization • Planned elective surgery during the study period (except cataract surgery, vascular access surgery, urethral stent removal, nephrostomy tube replacement, minor outpatient surgery not requiring hospitalization • Known HIV infection • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) to assess whether ESA treatment may modulate inflammatory and oxidative stress genes in patients with renal transplant; 2) to identify genomic patterns able to explain the complex link among anemia, microinflammation and oxidative stress; 3) to identify ESA unresponsive subjects.;Secondary Objective: 1) to assess whether ESA treatment may modulate inflammatory and oxidative stress genes in patients with renal transplant; 2) to identify genomic patterns able to explain the complex link among anemia, microinflammation and oxidative stress; 3) to identify ESA unresponsive subjects.;Primary end point(s): Changes of the inflammatory and oxidative stress genes in patients with renal transplant with eritropoietin | — |
Countries
Italy
Outcome results
None listed