NCT00077597

Brief Summary

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2004

Geographic Reach
13 countries

59 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

February 10, 2004

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin response rate

    Weeks 1-24

Secondary Outcomes (1)

  • Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

ACTIVE COMPARATOR
Drug: epoetin

Interventions

epoetinDRUG

3 times a week iv, as prescribed.

2
methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

0.4 micrograms/kg iv (starting dose) once every 2 weeks

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients \>=18 years of age;
  • chronic renal anemia;
  • dialysis therapy for at least 2 weeks before screening.

You may not qualify if:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of any investigational drug within 4 weeks before screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (59)

Unknown Facility

Davis, California, 95616, United States

Location

Unknown Facility

Lakewood, Colorado, 80260, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Augusta, Georgia, 30901, United States

Location

Unknown Facility

New Orleans, Louisiana, 70112, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Springfield, Massachusetts, 01107, United States

Location

Unknown Facility

Detroit, Michigan, 48202-2689, United States

Location

Unknown Facility

Mineola, New York, 11501, United States

Location

Unknown Facility

New York, New York, 10128, United States

Location

Unknown Facility

Toledo, Ohio, 43606, United States

Location

Unknown Facility

Houston, Texas, 77054, United States

Location

Unknown Facility

Burlington, Vermont, 05401, United States

Location

Unknown Facility

Norfolk, Virginia, 23507-1901, United States

Location

Unknown Facility

Curitiba, 81050-090, Brazil

Location

Unknown Facility

Ribeirão Preto, 14025-170, Brazil

Location

Unknown Facility

São Paulo, 01307-001, Brazil

Location

Unknown Facility

São Paulo, 04039-000, Brazil

Location

Unknown Facility

Calgary, Alberta, T2N 2T9, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Unknown Facility

Kingston, Ontario, K7L 3N6, Canada

Location

Unknown Facility

London, Ontario, N6A 5A5, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2C4, Canada

Location

Unknown Facility

Montreal, Quebec, H3A 1A1, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7K 1N4, Canada

Location

Unknown Facility

Liberec, 460 63, Czechia

Location

Unknown Facility

Prague, 169 00, Czechia

Location

Unknown Facility

Ústí nad Labem, 401 13, Czechia

Location

Unknown Facility

Alexandroupoli, 68100, Greece

Location

Unknown Facility

Larissa, 41 110, Greece

Location

Unknown Facility

Nikaia, 18354, Greece

Location

Unknown Facility

Thessaloniki, 54629, Greece

Location

Unknown Facility

Bergen, 5021, Norway

Location

Unknown Facility

Oslo, 0407, Norway

Location

Unknown Facility

Gdansk, 80-211, Poland

Location

Unknown Facility

Gdynia, 81-519, Poland

Location

Unknown Facility

Krakow, 31-501, Poland

Location

Unknown Facility

Lodz, 90-153, Poland

Location

Unknown Facility

Poznan, 60-355, Poland

Location

Unknown Facility

Szczecin, 70-111, Poland

Location

Unknown Facility

Wołomin, 05-200, Poland

Location

Unknown Facility

Wroclaw, 50-417, Poland

Location

Unknown Facility

Moscow, 123182, Russia

Location

Unknown Facility

Moscow, 125101, Russia

Location

Unknown Facility

Moscow, 129110, Russia

Location

Unknown Facility

Saint Petersburg, 195067, Russia

Location

Unknown Facility

Saint Petersburg, 197089, Russia

Location

Unknown Facility

Johannesburg, 2193, South Africa

Location

Unknown Facility

Soweto, South Africa

Location

Unknown Facility

Bilbao, 48013, Spain

Location

Unknown Facility

Santander, 39008, Spain

Location

Unknown Facility

Karlstad, 65185, Sweden

Location

Unknown Facility

Lausanne, 1011, Switzerland

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

Unknown Facility

Chon Buri, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 36791280DERIVED

  • Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000. doi: 10.1053/j.ajkd.2007.08.013.

    PMID: 18037099DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Erythropoietincontinuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 12, 2004

Study Start

February 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(2)TH(4)US(14)ZA(2)PL(8)GR(4)NO(2)CA(9)BR(4)CZ(3)SE(1)CH(1)RU(5)