Trial · NCT00632125
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
NCT00632125, Phase 4, Completed, Sandoz; results first posted 2017-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v. Trials, record NCT00632125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00632125
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
- NCT number
- NCT00632125
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,695 participants, actual
- Lead sponsor
- Sandoz
- Conditions
- Chronic Kidney Disease
- Interventions
- HX575 recombinant human erythropoietin alfa
- First posted
- 2008-03-10
- Last updated
- 2017-07-11
- Results first posted
- 2017-07-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects | 6 months | Safety population: The safety population consists of all patients that received at least one dose of study drug | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects | HX575 | Drug-related AEs | 7 | 95% Confidence Interval 5.9 to 8.3 | percentage of participants |
| Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects | HX575 | EPO-related lack of efficacy events | 0.18 | 95% Confidence Interval 0.04 to 0.52 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HX575 | 1,695 | |
| Overall Study | COMPLETED | HX575 | 1,393 | |
| Overall Study | NOT COMPLETED | HX575 | 302 |
Source ClinicalTrials.gov
Adverse events378
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | HX575 | 136 | 1,695 | 163 |
| other | Nasopharyngitis | Infections and infestations | HX575 | 100 | 1,695 | 111 |
| other | Diarrhoea | Gastrointestinal disorders | HX575 | 161 | 1,695 | 208 |
| other | Nausea | Gastrointestinal disorders | HX575 | 105 | 1,695 | 148 |
| other | Vomiting | Gastrointestinal disorders | HX575 | 102 | 1,695 | 121 |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | HX575 | 223 | 1,695 | 429 |
| other | Procedural hypotension | Injury, poisoning and procedural complications | HX575 | 111 | 1,695 | 194 |
| other | Hypertension | Vascular disorders | HX575 | 174 | 1,695 | 342 |
| other | Hypotension | Vascular disorders | HX575 | 145 | 1,695 | 298 |
| other | Headache | Nervous system disorders | HX575 | 181 | 1,695 | 299 |
1 to 10 of 378Source ClinicalTrials.gov
See all 378 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HX575 | 82 | 1,695 |
| Total, other adverse events | HX575 | 1,314 | 1,695 |
| Total, serious adverse events | HX575 | 456 | 1,695 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22732334 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00632125
GET https://conductscience.org/api/trials/v1/NCT00632125/events?page=2