Anaemia in Patients with Chronic Renal Failure (CRF) not on Dialysis and not on Erythropoiesis Stimulating Agent (ESA) Treatment MedDRA version: 9.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia
Conditions
Interventions
Product Code: AF37702 Injection
Pharmaceutical Form: Injection*
INN or Proposed INN: AF37702 injection
CAS Number: 913976-27-9
Current Sponsor code: AF37702
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Affymax Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has been 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 4 weeks prior to randomization, and must be willing to continue contraception until at least 4 weeks after the last dose of study treatment. 4. Chronic Renal Failure with an estimated glomerular filtration rate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant or breast-feeding. 2. Treatment with an ESA in the 12 weeks prior to randomization. 3. Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule. 4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment. (Note: renal transplant patients who are at least 6 months post-transplant and have not had chronic dialysis post-transplant are eligible.) 5. Known bleeding or coagulation disorder. 6. 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, myelodysplastic syndrome etc.). 7. Poorly controlled hypertension within 4 weeks prior to randomization, per Investigator’s clinical judgment. 8. Any clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent. 9. 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 metastatis, 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). 10. A scheduled kidney transplant (Note: patients currently on a transplant wait list are not excluded unless there is an identified donor). 11. Scheduled surgery that may be expected to lead to significant blood loss. 12. RBC or whole blood transfusion within 12 weeks prior to randomization. 13. Previous exposure to any investigational agent within 4 weeks prior to randomization, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period. 14. Previous exposure to AF37702 Injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the safety and efficacy of AF37702 Injection in the correction of anemia in patients with CRF not on dialysis and not on ESA treatment • To demonstrate the non-inferiority of AF37702 Injection to darbepoetin alfa in increasing Hgb in patients with CRF not on dialysis and not on ESA treatment ;Secondary Objective: ;Primary end point(s): Primary Efficacy Endpoint Mean change in Hgb between baseline and the Evaluation Period. The baseline Hgb value is defined as the mean of three Hgb values: the two most recent Hgb values taken prior to the day of randomization and the value obtained on the day of randomization. The mean Hgb during the Evaluation Period for each patient will be calculated as the mean of the available Hgb values during Study Weeks 25 through 36. | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Italy, Poland, Spain, United Kingdom
Outcome results
None listed