Anaemia MedDRA version: 9.1 Level: LLT Classification code 10058116 Term: Nephrogenic anaemia
Conditions
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined according to the following criteria: 1. The subject is male or female and aged 18 to 90 years, inclusive. 2. The subject is capable of understanding and complying with protocol requirements. 3. The subject or the subject’s legally authorised representative (if appropriate) 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 =3 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 =50% change from the maximum prescribed weekly dose (ie, [max-min]/max =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 =10.0 and =12.0 g/dL during the Screening Period, with the difference between the mean of the first 2 consecutive Hgb values and the mean of the last 2 consecutive Hgb values being =1.0 g/dL. Qualifying Hgb values must be taken 2 or more days between Hgb values with a maximum of 2 Hgb with one calendar week and 9 or more days between the first and the last of the 4 qualifying Hgb values. (Note: a maximum of 6 Hbg values may be obtained during a screening effort). 8. The subject has 1 ferritin level =100 ng/mL within 4 weeks prior to enrollment. 9. The subject has 1 serum folate level = lower limit of normal within 4 weeks prior to enrollment. 10. The subject has 1 vitamin B12 level = lower limit of normal within 4 weeks prior to enrollment. 11. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any subject who meets any of the following criteria will not qualify for entry into the study: 1. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after end of dosing this study; or intending to donate ova during such time period. 2. The subject has known intolerance to any erythropoiesis-stimulating agent, all 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 cell 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 received a recent course of intensive iron replacement (ie, has received more than 500 mg IV (intravenous) in the 28 days prior to enrollment). 7. The subject has poorly controlled hypertension within 4 weeks prior to enrollment, per investigator’s clinical judgment. 8. The subject has advanced chronic congestive heart failure – New York Heart Association Class III or IV. 9. The subject has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc). 10. The subject has a known history of seizure disorder or received anti-epileptic medication for seizure disorder within 6 months prior to enrollment. 11. The subject has a history of peritonitis within the 2 months prior to enrollment. 12. The subject has any clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent. 13. The subject has evidence of active malignancy within past 5 years (except nonmelanoma skin cancer or carcinoma-in-situ that has been completely excised). 14. The subject has a scheduled kidney transplant (Note: subjects currently on a transplant wait list are not excluded unless there is an identified donor). 15. The subject is anticipated to change dialysis modality during the course of the study. 16. The subject has a scheduled surgery that may be expected to lead to significant blood loss. 17. The subject has previous exposure to any investigational agent within 4 weeks prior to enrollment, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period. 18. The subject has previous exposure to AF37702 Injection. 19. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to enrollment. 20. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee, involved in conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: • To demonstrate that AF37702 Injection can maintain hemoglobin (Hgb) levels in peritoneal dialysis subjects following conversion from epoetin (alfa or beta).;Secondary Objective: The secondary objectives of this study are: • To determine the proportion of subjects who have a Hgb target of 10 to 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.;Primary end point(s): Primary Efficacy Endpoint Mean change in Hgb between Baseline (the mean of the 4 most recent Hgb values prior to enrollment plus the Hgb value on the day of enrollment) and the evaluation period (mean Hgb from weeks 20 to 25). Secondary Efficacy Endpoints • Proportion of subjects who have mean Hgb values within the target range of 10.0 to 12.0 g/dL during the evaluation period. • Proportion of subjects with a change in Hgb between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment plus the Hgb value on the day of enrollment) and the evaluation period (mean Hgb from weeks 20 to 25) of = ± 1 g/dL. • Proportion of subjects who receive RBC transfusions during the Titration Period and the Evaluation Period. • Mean Hgb during 4-week intervals (weeks 1-4, 5-8, etc)until completion of the evaluation phase of the study. • Proportion of subjects who maintain a target Hgb of 10.0 to 12.0 g/dL during 4-week intervals (weeks 1-4, 5-8, etc) until completion of the evaluation phase of the study. • Proportion of subjects requiring dose adjustments during the study. • Safety Endpoint: – Adverse events (AEs) and serious adverse events (SAEs). – Physical examination (including dry weight, vital signs, and oral temperature). – Clinical laboratory tests. | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed