E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Maintenance treatment of anemia in hemodialysis patients
Tratamiento de mantenimiento de la anemia en pacientes en hemodiálisis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002272 |
E.1.2 | Term | Anemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the safety and efficacy of AF37702 Injection in the maintenance treatment of anemia in hemodialysis patient. To demonstrate the non-inferiority of AF37702 Injection to Epoetin in the maintenance treatment of anemia. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines. 2. Males or females >= 18 years of age. 3. Females of child-bearing potential who are sexually active must be willing to practise a highly effective method of birth control for at least 4 weeks prior to randomization, and must be willing to continue birth control until at least 4 weeks after the last dose study treatment. 4. Patients with chronic renal failure on hemodialysis for >= 3 months prior to randomization. 5. On stable IV or SC Epoetin maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization. Stability is defined as =< 30% change from the maximum prescribed weekly dose (i.e., [max-min]/max =<0.3) with no change in prescribed frequency. 6. Four consecutive Hgb values with a mean >=10.0 and =< 12.0 g/dL during the Screening Period, with =< 1.3 g/dL difference between any of the four values taken no less than 3 days apart. (Note: a maximum of six Hgb values may be obtained during a screening effort) 7. One transferrin saturation (TSAT) >= 20% within 4 weeks prior to randomization. 8. One ferrin level >= 100ng/mL within 4 weeks prior to randomization. 9. One serum or red cell folate level >= lower limit of normal within 4 weeks prior to randomization. 10. One vitamin B12 level >= lower limit of normal within 4 weeks prior to randomization. |
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E.4 | Principal exclusion criteria |
1. Females who are pregnant or breast-feeding. 2. Known intolerance to any ESA, parenteral iron supplementation, or PEGylated products. 3. Known bleeding or coagulation disorder. 4. Known hematologic disease or cause for anemia other than renal disease (e.g., pure red cell aplasia [PRCA], homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic syndrome). 5. Poorly controlled hypertension within 4 weeks prior to randomization, per Investigator's clinical judgment. 6. Any clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent. 7. Evidence of active malignancy within one year prior to randomization. (Note for the purposes of this protocol, active malignancy does not include: non-melanoma skin cancer, carcinoma in situ that has been completely excised, other cancers for which treatment was completed at least one year ago with no continuing treatment and no evidence of metastasis, and other cancers that were diagnosed and treatment completed more than one year ago and within the past year are without evidence of metastasis and treated only with adjuvant hormonal therapy). 8. Temporary (untunneled) dialysis access catheter. 9. A scheduled kidney transplant (Note: patients currently on a transplant wait list are not excluded unless there is an identified donor). 10. A scheduled elective surgery that may be expected to lead to significant blood loss. 11. RBC or whole blood transfusion within 12 weeks prior to randomization. 12. Previous exposure to any investigational agent within 4 weeks prior to randomization, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period. 13. Previous exposure to AF37702 Injection. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change in Hgb between baseline (the mean of the five most recent Hgb values prior to randomization) and the Evaluation Period (mean Hgb from Weeks 29 through 36) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 78 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |