Trial · NCT00090753

A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

NCT00090753, Phase 3, Completed, Hoffmann-La Roche; results first posted 2012-01-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia. Trials, record NCT00090753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00090753

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
NCT number: NCT00090753
Status: Completed
Phases: Phase 3
Enrollment: 1,228 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Anemia
Interventions: Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa, Epoetin beta, Darbepoetin alfa
First posted: 2004-09-06
Last updated: 2012-02-14
Results first posted: 2012-01-05

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	Baseline to the end of the study (Up to 49 Months)	Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.
Secondary	Percentage of Patients Who Had at Least 1 Adverse Event	From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)	See the adverse events section of the results for more information.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	Baseline to the end of the study (Up to 49 Months)	Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.	g/dL	MEAN
SECONDARY	Percentage of Patients Who Had at Least 1 Adverse Event	From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)	Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	Methoxy Polyethylene Glycol-Epoetin Beta	-0.55	Standard Deviation 1.832	g/dL
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	Comparator ESA	-0.38	Standard Deviation 1.614	g/dL
Percentage of Patients Who Had at Least 1 Adverse Event	Methoxy Polyethylene Glycol-Epoetin Beta	94.3		Percentage of participants
Percentage of Patients Who Had at Least 1 Adverse Event	Comparator ESA	93.3		Percentage of participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Treatment Period	STARTED	Methoxy Polyethylene Glycol-Epoetin Beta	748
First Treatment Period	STARTED	Comparator ESA	480
First Treatment Period	COMPLETED	Methoxy Polyethylene Glycol-Epoetin Beta	492
First Treatment Period	COMPLETED	Comparator ESA	302
First Treatment Period	NOT COMPLETED	Methoxy Polyethylene Glycol-Epoetin Beta	256
First Treatment Period	NOT COMPLETED	Comparator ESA	178
Extended Treatment Period	STARTED	Methoxy Polyethylene Glycol-Epoetin Beta	453
Extended Treatment Period	STARTED	Comparator ESA	250
Extended Treatment Period	COMPLETED	Methoxy Polyethylene Glycol-Epoetin Beta	94
Extended Treatment Period	COMPLETED	Comparator ESA	59

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events1,398

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
other	NASOPHARYNGITIS	Infections and infestations	Methoxy Polyethylene Glycol-Epoetin Beta	107	748
other	NASOPHARYNGITIS	Infections and infestations	Comparator ESA	64	480
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Methoxy Polyethylene Glycol-Epoetin Beta	81	748
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Comparator ESA	63	480
other	URINARY TRACT INFECTION	Infections and infestations	Methoxy Polyethylene Glycol-Epoetin Beta	77	748
other	URINARY TRACT INFECTION	Infections and infestations	Comparator ESA	57	480
other	BRONCHITIS	Infections and infestations	Methoxy Polyethylene Glycol-Epoetin Beta	75	748
other	BRONCHITIS	Infections and infestations	Comparator ESA	49	480
other	INFLUENZA	Infections and infestations	Methoxy Polyethylene Glycol-Epoetin Beta	48	748
other	INFLUENZA	Infections and infestations	Comparator ESA	23	480

1 to 10 of 1,398Source ClinicalTrials.gov

See all 1,398 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Methoxy Polyethylene Glycol-Epoetin Beta
Total, all-cause mortality	Comparator ESA
Total, other adverse events	Methoxy Polyethylene Glycol-Epoetin Beta	624	748
Total, other adverse events	Comparator ESA	390	480
Total, serious adverse events	Methoxy Polyethylene Glycol-Epoetin Beta	499	748
Total, serious adverse events	Comparator ESA	316	480

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Methoxy Polyethylene Glycol-Epoetin Beta vs Comparator ESA: serious adverse events

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00090753

GET https://conductscience.org/api/trials/v1/NCT00090753/events?page=2

API reference For AI assistants