Anaemia in patients with chronic kidney disease not on dialysis (pre-dialysis patients).
Conditions
Interventions
Product Name: AF37702 Injection
Product Code: AF37702, Hematide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not yet received
CAS Number: Not given
Current Sponsor code: AF37702
Ot
Sponsors
Affymax, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject has signed a written, witnessed informed consent. Males or females, including women of childbearing potential on a highly effective method of birth control, age 18 - 85 years. GFR of = 60 mL/min. Hemoglobin = 9.0 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any previous exposure to investigational or commercially available erythropoiesis stimulating agents (ESAs) in the 12 weeks prior to study enrollment, prior treatment with Eprex, intolerance of any ESA. History of PRCA. RBC transfusion within 12 weeks. Hemoglobinopathy, hemolysis, inflammatory disease, CRP > 30 mg/L, significant infection, febrile illness, hyperparathyroidism, poorly controlled hypertension, epileptic seizures, CHF (NYHA Class IV). Significant medical diseases or conditions, including history of MI, coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, liver disease, active HIV disease, significant history of multiple drug allergies, or other diseases within the past 6 months that may interfere with patient assessment. Malignancy within past 5 years, life-expectancy < 12 months, anticipated elective surgery, previous exposure to any investigational drug within prior 6 weeks or expected during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the range of monthly (i.e., Q4W, every 4 weeks) doses of AF37702 Injection administered subcutaneously that increases and maintains hemoglobin at 11-13 g/dL in Chronic Kidney Disease (CKD) patients not on dialysis (pre-dialysis patients).;Secondary Objective: To evaluate the safety profile of up to six doses of AF37702 Injection administered subcutaneously on a Q4W schedule in pre-dialysis patients. To evaluate the pharmacokinetic profiles of up to six doses of AF37702 Injection administered subcutaneously on a Q4W schedule in pre-dialysis patients (in a subset of study patients). To evaluate the safety and pharmacodynamic profiles of up to six doses of AF37702 Injection administered intravenously on a Q4W schedule in pre-dialysis patients, with pharmacokinetic profiles in a subset of these patients. To evaluate the safety and pharmacodynamic profiles of AF37702 Injection administered subcutaneously once every two weeks (Q2W) for up to 12 doses, with pharmacokinetic profiles in a subset of these patients.;Primary end point(s): Hemoglobin change from baseline at weekly intervals through Week 13 and at 2-week intervals through Week 25 • Proportion of patients per cohort with hemoglobin within 11-13 g/dL at Weeks 9, 13, 17, 21, and 25 • Proportion of patients per cohort achieving a Hgb response, defined as a Hgb increase of = 1.0 g/dL from baseline and a Hgb = 11.0 g/dL during the study • Number (%) of patients with no dose adjustments during the study and number (%) of patients with dose increase or decrease during the study • Incidence of red blood cell transfusions during the study • Pharmacologic parameters including RBCs, hematocrit, reticulocyte counts, reticulocyte hemoglobin content, and serum measures of iron status (e.g., serum ferritin, transferrin saturation, and transferrin receptor protein) • Adverse events (AEs) • Serious adverse events (SAEs) • Pharmacokinetic parameters including Cmax, AUC0-t, AUC0-8, t½ß, Vd, Vss, and C | — |
Countries
United Kingdom
Outcome results
None listed