Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients

What Was Tested

This registered phase 3 trial tested Cyanocobalamin (Vitamin B12) for anemia.

It had two arms (groups): CinnaPoietin® (experimental) and Eprex® (active comparator).

The registry classes the interventions as drug.

More on the Plan

After signing the written informed consents, 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-weeks period.

The clinical trial will be conducted according to the GCP considerations.

A comprehensive validation check program is used to verify the data, and discrepancy reports are generated accordingly for resolution by the investigator.

The drugs will be relabeled, and the same label is used for both prefilled syringe.

Who Took Part

156 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged between 18 and 70. ESRD patients who are on hemodialysis for ≥3 months. 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;.

The full record lists 9 inclusion and 29 exclusion criteria; among the exclusions: 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 myeloma, aplastic anemia, leukemia;….); decompensated liver failure;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the anemia participants stayed in one arm throughout.

Blinding on both sides kept the anemia participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-06-22 with completion listed for 2017-07-19.

It ran at 8 sites in Iran (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Hb Change Level During the Last Four Weeks of Treatment (time frame: Week 22 to week 26).

It also tracked 10 secondary outcomes, for example The Proportion of Patients Needed Blood Transfusions, The Proportion of Patients With Treatment Success, The Proportion of Patients With Maintenance Success and The Incidence of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 156 people with anemia.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, Anemia research.