Chronic kidney disease. Chronic kidney disease
Conditions
Interventions
Intervention 1: In Cinnapoeitin group, the starting dose is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropetin is similar dose of
Treatment - Drugs
In Cinnapoeitin group, the starting dose is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropetin is similar dose of previously admi
In Eprex group, the starting dose is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropetin is similar dose of previously administere
Sponsors
CinnaGen Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • 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. Exclusion Criteria: • 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 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.somayeh Amini
Orchidpharmed company
Outcome results
None listed