A Phase 3 interventional study of HX575 epoetin alfa (Sandoz) in Chronic Kidney Disease, sponsored by Sandoz. Completed at 50 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-19.
Sponsored by Sandoz · Phase 3, Interventional, and Treatment
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 417 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Single arm
Drug: HX575 epoetin alfa (Sandoz)
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Also known as: Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®
Anti-Erythropoietin (EPO) Antibodies
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Time frame: 52 weeks
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
Time frame: 52 weeks
Patients, suffering from anemia associated with chronic Kidney Disease (CKD), were treated s.c. with HX575 at least once per week in order to achieve and maintain Hb concentration within the target range of 10.0 to 12.0 g/dL. 417 patients were enrolled.
| Milestone | HX575, Safety Population |
|---|---|
| Started | 417 |
| Completed | 324 |
| Not completed | 93 |
| Withdrew: Withdrawal by subject | 24 |
| Withdrew: Adverse event | 10 |
| Withdrew: Death | 21 |
| Withdrew: Physician decision | 2 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Kidney transplantation | 10 |
| Withdrew: Protocol violation | 12 |
| Withdrew: Other | 12 |
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
| percentage of participants | HX575 |
|---|---|
| Anti-Erythropoietin (EPO) Antibodies | 1.7 (0.7 to 3.4) |
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
| g/dL | HX575 - ESA Naive | HX575 - ESA Maintenance | HX575 |
|---|---|---|---|
| Actual Value | 10.81 ± 1.336 | 10.86 ± 1.060 | 10.83 ± 1.226 |
| Change from Baseline Period | 1.61 ± 1.601 | 0.22 ± 1.223 | 1.02 ± 1.606 |
Collected over 4 weeks (screening period) + 52 weeks (treatment period). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HX575, Safety Population | 25/416 (6%) | 103/416 (24.8%) | 121/416 (29.1%) |
| Event | HX575, Safety Population |
|---|---|
| Renal failure chronicRenal and urinary disorders | 20/416 |
| Myocardial infarctionCardiac disorders | 5/416 |
| PeritonitisInfections and infestations | 5/416 |
| PneumoniaInfections and infestations | 5/416 |
| HypertensionVascular disorders | 5/416 |
| Angina pectorisCardiac disorders | 3/416 |
| Cerebrovascular accidentNervous system disorders | 3/416 |
| Acute coronary syndromeCardiac disorders | 2/416 |
| Acute myocardial infarctionCardiac disorders | 2/416 |
| Angina unstableCardiac disorders | 2/416 |
| Event | HX575, Safety Population |
|---|---|
| HypertensionVascular disorders | 42/416 |
| Renal failure chronicRenal and urinary disorders | 39/416 |
| HyperkalaemiaMetabolism and nutrition disorders | 19/416 |
| NasopharyngitisInfections and infestations | 13/416 |
| PneumoniaInfections and infestations | 10/416 |
| DiarrhoeaGastrointestinal disorders | 9/416 |
| Oedema peripheralGeneral disorders | 9/416 |
| Urinary tract infectionInfections and infestations | 9/416 |
Safety population: The safety population consists of all patients that received at least one dose of study drug
| Age, Continuous(years) | HX575, Safety Population |
|---|---|
| Mean | 52.3 ± 15.78 |
| Sex: Female, Male(Participants) | HX575, Safety Population |
|---|---|
| Female | 218 |
| Male | 198 |
| Race (NIH/OMB)(Participants) | HX575, Safety Population |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 416 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | HX575, Safety Population |
|---|---|
| Russian Federation | 107 |
| Romania | 40 |
| Turkey | 33 |
| Ukraine | 179 |
| Poland | 47 |
| Italy | 5 |
| Germany | 5 |
| Height(cm) | HX575, Safety Population |
|---|---|
| Mean | 166.9 ± 9.44 |
| Weight(kg) | HX575, Safety Population |
|---|---|
| Mean | 70.6 ± 15.92 |
| Body Mass Index (BMI)(kg/m^2) | HX575, Safety Population |
|---|---|
| Mean | 25.26 ± 5.073 |
| ESA pre-treatment(participants) | HX575, Safety Population |
|---|---|
| ESA naive | 250 |
| ESA maintenance | 166 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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