E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10002045 |
E.1.2 | Term | Anaemia haemolytic |
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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 |
Primary Objectives: The primary objective ofthis study is: To demonstrate that AF37702 Injection can maintain hemoglobin (Hgb) levels in peritoneal dialysis subjects following conversion from epoetin (alfa or beta). |
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E.2.2 | Secondary objectives of the trial |
Seeondary Objectives: The secondary objectives ofthis study are: Io determine the proportion of subjects who have a Hgb target of lOto 12 g/dL following conversion from epoetin (alfa or beta) to AF37702 Injection. Evaluate the safety profile of AF37702 Injection in peritoneal dialysis subjects who were previously receiving epoetin (alfa or beta). The exploratory objective of this study is: To evaluate change from Baseline in patient-reported outcomes (PRO) assessment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main Criteria for Inc\usion: Subject eligibility is determined according to the following criteri a: l. The subject is male or female and aged 18 to 90 years, inclusi ve. 2. The subject is capable ofunderstanding and complying with protocol requirements. 3. Tbe subject or the subject`s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures. 4. A female subject of childbearing potential who is sexually active agrees to routinely use acceptable contraception from Screening throughout the duration of the study, 5. The subject has chronic renal failure and has been on peritoneal dialysis for 23 months prior to enrollment. 6. The subject is on stable SC epoetin (alfa or beta) maintenance therapy continuously prescribed for a minimum of 8 weeks prior to enrollment. Stability is defined as :5:50% change from the maximum prescribed weekly dose (ie, [max-min]/max :5:0.5) with no change in prescribed frequency during the 4 weeks prior to enrollment. 7. The subject has 4 consecutive Hgb values with a mean 210.0 and :5:12.0 g/dL during the Screening Period, with the difference between the mean of the first 2 consecuti ve Hgb values and the mean of the last 2 consecutive Hgb values being :5:1.0g/dL. Qualifying Hgb values must be taken 2 or more days between Hgb values with a maximum of2 Hgb with one calendar week and 9 or more days between the first and the last ofthe 4 qualifying Hgb values. (Note: a maximum of 6 Hbg values may be obtained during a screening effort). 8. The subject has l ferritin level z l Ou` ng/mL within 4 weeks prior to enrollment. 9. The subject has 1 serum or red cell folate level z lower limit ofnormal within 4 weeks prior to enrollment. lO. The subject has l vitamin B 12 leve! ;;::lower limit of nonnal within 4 weeks prior to enrollment. Il. The subject has a negative test result for hepatitis B surface antigen, and hepatitis C virus antibody at Screening and no known history of human immunodeficiency virus infection. |
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E.4 | Principal exclusion criteria |
Main Criteria for Exclusion: Any subject who meets any ofthe following criteria will not qualify for entry into the study: 1. If female, the subject is pregnant or lactating or intending 10 become pregnant before, during, or within l month after end of dosing this study; or intending to donate ova during such rime periodo 2. The subject has known intolerance to any erythropoiesis-stimulating agent, ali parenteral iron supplementation products, or any PEGylated molecules. 3. The subject has known bleeding or coagulation disorder. 4. The subject has known hematologic disease or cause of anemia other than renal disease (eg, pure red cel1 aplasia [PRCA], homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic syndrome). 5. The subject has had red blood cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment. 6. The subject has recei ved a recent course of intensi ve iron replacement (ie, has recei ved more than 500 mg IV |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint Mean change in Hgb between Baseline (the mean of the 4 most recent Hgb val ues prior to enrollment plus the Hgb value on the day of enrollment) and the evaluation period (mean Hgb from weeks 20 to 25). |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
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 | 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
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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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |