E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anemia in Hemodialysis Patients |
|
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 | 10002034 |
E.1.2 | Term | Anaemia |
|
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 patients To demonstrate the non-inferiority of AF37702 Injection to Epoetin in the maintenance treatment of anemia |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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 practice a highly effective method of birth control for at least four weeks prior to randomization and must be willing to continue birth control until at least four weeks after the last dose of 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 ferritin level ≥ 100 ng/mL within 4 weeks prior to randomization. |
|
E.4 | Principal exclusion criteria |
Exclusion Criteria 1. Females who are pregnant or breast-feeding. 2. Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecules. 3. Known bleeding or coagulation disorder. 4. Known hematologic disease or cause of 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 Investigators clinical judgment. 6. Any clinically significant medical disease or condition that, in the Investigators opinion, may interfere with protocol adherence or a patients 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Endpoint Mean change in Hgb between baseline (the mean of the five most recent Hgb values taken prior to and/or on the day of randomization) and the Evaluation Period (mean Hgb from Weeks 29 through 36) |
|
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 | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
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 |
|
E.8.7 | Trial has a data monitoring committee | No |
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
| |
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 | |
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 |