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Renal Anemia, ChronicPhase 3NCT00559273

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta and Darbepoetin alfa in people with Renal Anemia, Chronic, run by Hoffmann-La Roche at 76 sites in 16 countries.

Completed

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

Official record
Search all trials

Trial summary

This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Anemia, Chronic
What is being tested?
Methoxy polyethylene glycol-epoetin beta and Darbepoetin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
307 participants
Where
76 sitesin 16 countries
Study dates
Dec 2007to Oct 2009
Phase
Phase 3
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

  • Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance [CrCl]/ glomerular filtration rate [GFR] 30 to 59 milliliter per minutes per 1.73 meter square [mL/min/1.73m^2]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m^2) who did not require dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated Modification of Diet in Renal Disease (MDRD) equation
  • Anemia defined as baseline Hb concentration less than (<) 10.5 gram per deciliter (g/dL)

Who cannot join

  • Previous therapy with any ESA within 12 weeks prior to screening
  • Renal allograft in place
  • Immunosuppressive therapy in the 12 weeks prior to screening
  • Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening

Trial locations and contacts

76 sites in 16 countries.

76 sites in 16 countries

Poland10 sites

  • Study site

    Gdansk, 80-211

  • Study site

    Katowice, 40-027

  • Study site

    Krakow, 31-501

  • Study site

    Lodz, 90-153

  • Study site

    Radom, 26-610

  • Study site

    Rzeszów, 35-055

  • Study site

    Sieradz, 98-200

  • Study site

    Szczecin, 70-111

  • Study site

    Warsaw, 02-006

  • Study site

    Wroclaw, 50-417

Other trials in Poland

Russia8 sites

  • Study site

    Moscow, 117036

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 129110

  • Study site

    Saint Petersburg, 191015

  • Study site

    Saint Petersburg, 195067

  • Study site

    Saint Petersburg, 197089

  • Study site

    Saint Petersburg, 197110

  • Study site

    Saratov, 410053

Other trials in Russia

Spain8 sites

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08907

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28922

  • Study site

    Palma de Mallorca, 07014

  • Study site

    Seville, 41009

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46017

Other trials in Spain

France6 sites

  • Study site

    Cahors, 46005

  • Study site

    Clermont-Ferrand, 63000

  • Study site

    Limoges, 87042

  • Study site

    Lyon, 69437

  • Study site

    Nice, 06002

  • Study site

    Paris, 75651

Other trials in France

Italy6 sites

  • Study site

    Como, 22100

  • Study site

    Lecco, 23900

  • Study site

    Lodi, 26900

  • Study site

    Mestre, 30174

  • Study site

    Modena, 41100

  • Study site

    Pavia, 27100

Other trials in Italy

Australia5 sites

  • Study site

    Adelaide, 5011

  • Study site

    Clayton, 3186

  • Study site

    Gosford, 2250

  • Study site

    Parkville, 3052

  • Study site

    Reservoir, 3073

Other trials in Australia

Hungary5 sites

  • Study site

    Baja, 6500

  • Study site

    Budapest, 1071

  • Study site

    Esztergom, 2500

  • Study site

    Hatvan, 3000

  • Study site

    Szigetvár, 7390

Other trials in Hungary

Thailand5 sites

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Bangkok

  • Study site

    Nakhon Ratchasima, 30000

  • Study site

    Pathum Thani, 12120

Other trials in Thailand

Canada4 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Germany4 sites

  • Study site

    Berlin, 13353

  • Study site

    Bonn, 53127

  • Study site

    Heilbronn, 74076

  • Study site

    Homburg/saar, 66424

Other trials in Germany

Greece4 sites

  • Study site

    Alexandroupoli, 68100

  • Study site

    Larissa, 41 110

  • Study site

    Thessaloniki, 54636

  • Study site

    Volos, 38222

Other trials in Greece

Israel3 sites

  • Study site

    Haifa, 34362

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, 49100

Other trials in Israel

South Korea3 sites

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 133-792

  • Study site

    Seoul

Other trials in South Korea

Belgium2 sites

  • Study site

    Aalst, 9300

  • Study site

    Roeselare, 8800

Other trials in Belgium

Taiwan2 sites

  • Study site

    Taichung, 407

  • Study site

    Taipei, 100

Other trials in Taiwan

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

About this study

Official title: An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis

This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.

Being tested
Methoxy polyethylene glycol-epoetin beta, Darbepoetin alfa
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

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

  • Methoxy polyethylene glycol-epoetin betaDrug

    Also called Mircera, RO0503821

    1.2 mcg/kg SC monthly, starting dose

  • Darbepoetin alfaDrug

    0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose

Study groups in NCT00559273
Study groupRoleWhat they receive
MirceraExperimentalParticipants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
Receives: Drug: Methoxy polyethylene glycol-epoetin beta
Darbepoetin AlfaActive comparatorParticipants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
Receives: Drug: Darbepoetin alfa

What is being measured

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

  1. Percentage of Participants With Hemoglobin (Hb) Response

    Hb response was an observed increase in Hb greater than or equal to (>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.

    Measured: Baseline up to Week 28

  2. Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period

    A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.

    Measured: Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)

Secondary outcomes (6)

  1. Hemoglobin (Hb) Concentration Over the Time

    The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.

    Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)

  2. Time to Hemoglobin Response

    Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb >=1.0 g/dL from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without RBC transfusion before response.

    Measured: Baseline up to Week 28

  3. Percentage of Participants With Red Blood Cell (RBC) Transfusions

    The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.

    Measured: Baseline up to Week 28

  4. Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL

    Percentage of participants having at least one Hb value greater than (>) 12 g/dL during the first 8 weeks of the study was reported.

    Measured: Baseline to Week 8

  5. Percentage of Participants With Stable Hemoglobin Response

    A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.

    Measured: Baseline to Week 28

  6. Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response

    The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.

    Measured: Baseline to Week 28

Timeline

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

  1. First posted16 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559273
Sponsor's protocol ID
NH20052
Status last verified
Sep 2016
First submitted
15 Nov 2007
Last updated
1 Nov 2016

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta and Darbepoetin alfa in people with Renal Anemia, Chronic, run by Hoffmann-La Roche at 76 sites in 16 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 2 inclusion and 4 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Poland, Russia, Spain, France, Italy and 11 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 1 Nov 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?

Percentage of Participants With Hemoglobin (Hb) Response (time frame: Baseline up to Week 28). The study lists 2 primary outcomes in all. 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 NCT00559273, which also lists 1 linked publication.

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 1 Nov 2016.

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