E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 evaluate the safety and tolerability of AF37702 treatment for the long term maintenance of hemoglobin (Hgb) in patients with Chronic Kidney Disease (CKD). |
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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 |
a. Patient is informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines b. Males or females ≥ 18 years of age. c. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some (IUDs), sexual abstinence or vasectomized partner. d. Patient with CKD who has received at least 24 weeks of AF37702 Injection dosing (e.g., 6 doses administered Q4W or 12 doses administered Q2W) in a previous Affymax-sponsored study. e. One Hgb value of ≥ 10.0 g/dL in the 4 weeks prior to study drug administration. |
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E.4 | Principal exclusion criteria |
a. Known intolerance to AF37702 Injection and PEGylated products b. History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA) c. High likelihood of early withdrawal or interruption of the study (e.g., patient suffers from any clinically significant medical disease or condition that may, in the Investigator’s opinion, interfere with safety, assessment, or follow-up of the patient) d. Anticipated life expectancy < 18 months e. Receipt of any commercially available ESA other than AF37702 at any time after patient enrollment in the previous Affymax-sponsored study |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Incidence of adverse events (AEs). - Incidence of serious adverse events (SAEs), including deaths - Incidence of AF37702-specific antibody formation - Incidence of red blood cell (RBC) or whole blood transfusions and phlebotomies· - Number and proportion of patients who maintain Hgb within 10.0 to 12.0 g/dL· - Hgb level and changes in Hgb - AF37702 injection doses - Number and proportion of subjects with dose adjustments - Vital signs and laboratory values (hematology, chemistry, and iron status.
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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 | 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) | 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 | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |