CinnaPoietin® versus Eprex® on treatment of anemia in End stage renal disease (ESRD ) hemodialysis patients
- Conditions
- Chronic kidney disease.Chronic kidney disease
- Registration Number
- IRCT201601156135N6
- Lead Sponsor
- CinnaGen Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 156
•Aged between 18 and 70
•ESRD patients who are on hemodialysis for =3 months.
•Hb level 8- 11.5 g/dl
•Patients are on adequate hemodialysis: the minimally adequate dose of hemodialysis given 3 times per week should be a spKt/V (single-pool delivered Kt/V; clearance of urea x dialysis time/volume of distribution) of 1.2 per dialysis. For treatment periods of less than 5 hours, an alternative minimum dose is a urea reduction rate (URR) of 65%. All types of hemodialysis systems and hemodiafiltration, including high-flux membranes are allowed as long as there is no plan to change the patient’s regimen during the study.
•Sufficient iron stores, defined as serum ferritin = 200 ng/ml and transferrin saturation =20%. (Patients not meeting these criteria may receive iron supplementation therapy during the Screening and stabilization period to appropriately correct their iron store deficiency to meet the criterion required for randomization);
•who present iron stores according to the KDIGO guidelines;
•Ability to comply with study medication use, study visits, and study procedures as judged by the investigator;
•Females of childbearing potential agree to use an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) for the duration of the study.
•Qualified and willing to sign the informed consent form with the commitment of complying with all the scheduled visits, and study procedures as judged by the investigator;
•In any circumstances that potential participants are not able to give consent, it may be given by responsible parents or guardian.
•Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure = 100 mmHg or systolic blood pressure =180 mmHg);
•Anemia secondary to other causes different to the CKD (e.g. multiple myoloma, aplastic anemia, leukemia;….)
•Decompensated liver failure;
•Clinical evidence of concurrent uncontrolled hyperparathyroidism (defined as serum parathyroid hormone (iPTH) > 800 pg/ml);
•Heart failure [New York Heart Association (NYHA) class III and IV];
•Unstable angina pectoris, active cardiac disease, stroke and/or cardiac infarction within the last six months;
•History of or active blood coagulation disorders including DVT, PTE, native access Thrombosis during last six months.
•Thrombocytosis (platelet count > 500,000/µl);
•Thrombocytopenia (platelet count < 100,000/µl);
•White blood cell count < 3,000/µl);
•White blood cell count >15,000)
•Recent Bleeding (acute or chronic bleeding within three months prior to screening);
•Suspicion of or confirmed occult bleeding (increased reticulocyte count);
•Clinical evidence of concurrent systemic infection, or inflammatory disease (e.g; diabetic foot, bed sore, access infection, CRP> 30,…)
•Currently receiving treatment for epilepsy;
•Major surgery within 3 months prior to randomization and during the conduct of the trial (except vascular access surgery);
•Concomitant immunosuppressive therapy; patients on a short course of steroids (up to 7 days), topical or intranasal steroids are allowed in the study;
•History of any malignant disease within the last 5 years (except excised non-melanoma skin cancer);
•Women who are pregnant or breastfeeding;
•Known history of severe drug-related allergies;
•Known history of drug related allergy to Erythropoietin or one of the ingredients of the test or the reference produc
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •mean Hb change level during the last 4 weeks of treatment. Timepoint: during 26 weeks every 2 week. Method of measurement: CBC test.;Mean weekly epoetin dosage per kg body weight during the last 4 weeks of treatment. Timepoint: during 26 weeks every 2 week. Method of measurement: Total dose administered.
- Secondary Outcome Measures
Name Time Method Proportion of patients with any permanent or transient dose change during main study phase. Timepoint: during 26 weeks every 2 week. Method of measurement: any dose change.;Proportion of patients with any Hb measurement outside the target range. Timepoint: during 26 weeks every 2 week. Method of measurement: CBC test.;Incidence of blood transfusions. Timepoint: during 26 weeks follow up. Method of measurement: count of blood transfusion event.;Proportion of patients with treatment success. Timepoint: during 26 weeks every 2 week. Method of measurement: Hb concentration=11.0 g/dl or two consecutive weeks without any blood transfusion within the preceding 3 months.;The incidence of Hb levels above 13 g/dL. Timepoint: during 26 weeks every 2 week. Method of measurement: CBC test.;Proportion of patients with an increase in Hb concentration of > 1.0 g/dL for 4 weeks. Timepoint: during 26 weeks every 2 week. Method of measurement: CBC test.