Chronic Kidney Disease
Conditions
Keywords
CKD subjects with or without dialysis treatment
Brief summary
Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.
Detailed description
This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions.
Interventions
HX575 epoetin alfa i.v. will be administered according to the SmPC
Sponsors
Hexal AG
Sandoz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CKD subjects with or without dialysis treatment * Age over 18 years * Subjects requiring i.v. ESA treatment * Subjects likely to remain on i.v. ESA treatment for 6 months * Provision of informed consent -
Exclusion criteria
* Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level * Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product * History of PRCA or aplastic anemia * History of anti-erythropoietin antibodies * Uncontrolled hypertension * Pregnant woman or nursing mother * Women of childbearing potential do not agree to maintain effective birth control during the study treatment period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects | 6 months | The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy |
Countries
Austria, Bulgaria, France, Germany, Italy, North Macedonia, Poland, Romania, Russia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HX575 HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the SmPC | 1,695 |
| Total | 1,695 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 36 |
| Overall Study | Death | 82 |
| Overall Study | Development of uncontrolled hypertension | 5 |
| Overall Study | Moved to other dialysis unit, etc. | 102 |
| Overall Study | Need for systemic immunosuppressive medi | 8 |
| Overall Study | Non-compliance | 8 |
| Overall Study | Renal transplantation | 17 |
| Overall Study | Withdrawal by Subject | 44 |
Baseline characteristics
| Characteristic | HX575 |
|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 15.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 1671 Participants |
| Region of Enrollment Austria | 44 participants |
| Region of Enrollment Bulgaria | 45 participants |
| Region of Enrollment France | 1 participants |
| Region of Enrollment Germany | 701 participants |
| Region of Enrollment Italy | 205 participants |
| Region of Enrollment Macedonia, The Former Yugoslav Republic of | 143 participants |
| Region of Enrollment Poland | 220 participants |
| Region of Enrollment Romania | 103 participants |
| Region of Enrollment Russian Federation | 29 participants |
| Region of Enrollment Ukraine | 204 participants |
| Sex: Female, Male Female | 737 Participants |
| Sex: Female, Male Male | 958 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 82 / 1,695 |
| other Total, other adverse events | 1,314 / 1,695 |
| serious Total, serious adverse events | 456 / 1,695 |
Outcome results
Primary
Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy
Time frame: 6 months
Population: Safety population: The safety population consists of all patients that received at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HX575 | Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects | Drug-related AEs | 7 percentage of participants |
| HX575 | Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects | EPO-related lack of efficacy events | 0.18 percentage of participants |