AnemiaPhase 2NCT00364832

A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

A Phase 2 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 23 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: methoxy polyethylene glycol-epoetin beta [Mircera]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 23 sitesin 4 countries
Study dates: Oct 2001to Jul 2005
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients >=18 years of age;
chronic renal anemia;
on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

Who cannot join

women who are pregnant, breastfeeding or using unreliable birth control methods;
use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.

Trial locations and contacts

23 sites in 4 countries.

Country

City, postcode or hospital

23 sites in 4 countries

Italy8 sites

Study site
Bari, 70124
Study site
Bergamo, 24128
Study site
Lecco, 23900
Study site
Lodi, 26900
Study site
Milan, 20122
Study site
Modena, 41100
Study site
Pavia, 27100
Study site
Vicenza, 36100

Other trials in Italy

United States6 sites

Study site
Boston, Massachusetts, 02130
Study site
Cleveland, Ohio, 44106
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90073
Study site
Morgantown, West Virginia, 26506
Study site
San Jose, California, 95116-1906

Other trials in United States

Spain5 sites

Study site
Barcelona, 08036
Study site
Madrid, 28007
Study site
Madrid, 28046
Study site
Málaga, 29010
Study site
Santander, 39008

Other trials in Spain

Germany4 sites

Study site
Berlin, 10625
Study site
Mannheim, 68167
Study site
Villingen-Schwenningen, 78054
Study site
Wiesloch, 69168

Other trials in Germany

About this study

Official title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia

Conditions: Anemia
Being tested: methoxy polyethylene glycol-epoetin beta [Mircera]
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

methoxy polyethylene glycol-epoetin beta [Mircera]Drug
Differing doses and frequencies of sc administration

Study groups in NCT00364832
Study group	Role	What they receive
Cohort A (0.4/150, 1x/ Week)	Experimental	Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort B (0.4/150, 1x/ 3 Weeks)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort C (0.4/150, 1x/ 4 Weeks)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort D (0.8/150, 1x/ Week)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort E (0.8/150, 1x/ 3 Weeks)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort F (0.8/150, 1x/ 4 Weeks)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort G (1.2/150, 1x/ Week)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort H (1.2/150, 1x/ 3 Weeks)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort I (1.2/150, 1x/ 4 Weeks)	Experimental	Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.
Measured: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)

Secondary outcomes (5)

Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.
Measured: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks -2 and -1).
Measured: From Baseline (Day -28 to Day 1) to Week 126
Mean Change in Pulse Rate
Mean change in pulse rate was reported.
Measured: Up to Week 126
Number of Participants With Marked Laboratory Abnormalities
Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L).
Measured: Up to Week 126
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Measured: Up to Week 126

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2001Jul 2005

First posted16 Aug 2006 (estimated)
Study startOct 2001
Primary completionJul 2005
Study completionJul 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00364832
Sponsor's protocol ID: BA16286
Status last verified: Oct 2016
First submitted: 15 Aug 2006
Last updated: 20 Dec 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, Beyer U; BA16286 Study Investigators. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007 May;23(5):969-79. doi: 10.1185/030079907x182103.
PubMed 17519064

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
ClinicalTrials.gov ID: NCT00364832
Acronym / sponsor ID: BA16286
Conditions: Anemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Oct 2001
Primary completion: Jul 2005 (actual)
Study completion: Jul 2005 (actual)
First posted: 16 Aug 2006 (estimated)
Results: Posted 20 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Cohort A (0.4/150, 1x/ Week)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort B (0.4/150, 1x/ 3 Weeks)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort C (0.4/150, 1x/ 4 Weeks)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort D (0.8/150, 1x/ Week)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort E (0.8/150, 1x/ 3 Weeks)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort F (0.8/150, 1x/ 4 Weeks)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort G (1.2/150, 1x/ Week)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort H (1.2/150, 1x/ 3 Weeks)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Cohort I (1.2/150, 1x/ 4 Weeks)	Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

adult patients >=18 years of age;
chronic renal anemia;
on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

Key exclusion criteria (2 listed)

women who are pregnant, breastfeeding or using unreliable birth control methods;
use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
methoxy polyethylene glycol-epoetin beta [Mircera]Differing doses and frequencies of sc administration	Drug	Cohort A (0.4/150, 1x/ Week), Cohort B (0.4/150, 1x/ 3 Weeks), Cohort C (0.4/150, 1x/ 4 Weeks), Cohort D (0.8/150, 1x/ Week), Cohort E (0.8/150, 1x/ 3 Weeks), Cohort F (0.8/150, 1x/ 4 Weeks), Cohort G (1.2/150, 1x/ Week), Cohort H (1.2/150, 1x/ 3 Weeks), Cohort I (1.2/150, 1x/ 4 Weeks)

Primary outcome

Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.

5 secondary outcomes

Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Time frame: From Baseline (Day -28 to Day 1) to Week 126
Mean Change in Pulse Rate
Time frame: Up to Week 126
Number of Participants With Marked Laboratory Abnormalities
Time frame: Up to Week 126
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
Time frame: Up to Week 126

Results and safety

Results posted to the registry on 20 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A (0.4/150, 1x/ Week)	16	14
Cohort B (0.4/150, 1x/ 3 Weeks)	15	13
Cohort C (0.4/150, 1x/ 4 Weeks)	15	14
Cohort D (0.8/150, 1x/ Week)	16	15
Cohort E (0.8/150, 1x/ 3 Weeks)	16	16
Cohort F (0.8/150, 1x/ 4 Weeks)	12	12
Cohort G (1.2/150, 1x/ Week)	16	12
Cohort H (1.2/150, 1x/ 3 Weeks)	15	14
Cohort I (1.2/150, 1x/ 4 Weeks)	16	16
RO0503821 (1x/ Week)	0	0
RO0503821 (1x/ 3 Weeks)	0	0
RO0503821 (1x/ 4 Weeks)	0	0

Primary outcome: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen

Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21). Median (Inter-Quartile Range). Unit: gram per deciliter

Measure	Cohort A (0.4/150, 1x/ Week) n = 16	Cohort B (0.4/150, 1x/ 3 Weeks) n = 15	Cohort C (0.4/150, 1x/ 4 Weeks) n = 15	Cohort D (0.8/150, 1x/ Week) n = 16	Cohort E (0.8/150, 1x/ 3 Weeks) n = 16	Cohort F (0.8/150, 1x/ 4 Weeks) n = 12	Cohort G (1.2/150, 1x/ Week) n = 16	Cohort H (1.2/150, 1x/ 3 Weeks) n = 15	Cohort I (1.2/150, 1x/ 4 Weeks) n = 16
Value	-0.80 (-1.60 to -0.36)	-0.60 (-1.01 to -0.16)	-0.29 (-0.91 to -0.23)	0.02 (-0.40 to 0.52)	-0.14 (-0.60 to 0.27)	-0.28 (-0.77 to 0.11)	0.65 (0.12 to 1.57)	0.33 (-0.11 to 1.14)	0.22 (-0.09 to 1.02)

Cohort A (0.4/150, 1x/ Week) vs Cohort D (0.8/150, 1x/ Week) vs Cohort G (1.2/150, 1x/ Week): Estimated Conversion Factor 90% CI: 0.81 (90% CI 0.73 to 0.90)
Cohort B (0.4/150, 1x/ 3 Weeks) vs Cohort E (0.8/150, 1x/ 3 Weeks) vs Cohort H (1.2/150, 1x/ 3 Weeks): Estimated Conversion Factor 90% CI: 0.72 (90% CI 0.55 to 0.86)
Cohort C (0.4/150, 1x/ 4 Weeks) vs Cohort F (0.8/150, 1x/ 4 Weeks) vs Cohort I (1.2/150, 1x/ 4 Weeks): Estimated Conversion Factor 90% CI: 0.93 (90% CI 0.81 to 1.09)

Population analysed: The ITT population was considered for analysis which included all randomized participants.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 126. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RO0503821 (1x/ Week)	15 of 48 (31.3%)	36 of 48 (75%)	Not reported
RO0503821 (1x/ 3 Weeks)	13 of 46 (28.3%)	30 of 46 (65.2%)	Not reported
RO0503821 (1x/ 4 Weeks)	20 of 43 (46.5%)	39 of 43 (90.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Derived from this study: PubMed 17519064Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, Beyer U; BA16286 Study Investigators. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007 May;23(5):969-79. doi: 10.1185/030079907x182103.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

23 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 23 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Italy, United States, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00364832, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.