NCT00605345

Brief Summary

This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

21 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

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

August 5, 2016

Completed
Last Updated

September 23, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

January 18, 2008

Results QC Date

April 19, 2016

Last Update Submit

August 17, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range

    Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.

    Weeks 16-28

Secondary Outcomes (5)

  • Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)

    Baseline to 28 weeks

  • Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)

    Weeks 16-28

  • Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)

    Weeks 16-28

  • Percentage of Participants Needing Dose Adjustments

    Up to 28 weeks

  • Incidence of RBC Transfusions

    Up to 28 weeks

Study Arms (2)

CERA Treatment Once Monthly

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

Darbepoetin Alfa Once Biweekly

ACTIVE COMPARATOR
Drug: Darbepoetin alfa

Interventions

Darbepoetin alfaDRUG

As prescribed

Darbepoetin Alfa Once Biweekly
methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

120, 200 or 360 micrograms sc 4-weekly (starting dose)

CERA Treatment Once Monthly

Eligibility Criteria

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

You may qualify if:

  • adult patients, \> or = 18 years of age;
  • kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
  • functioning graft of \> 6 months and \< 10 years after kidney transplantation, with no signs of acute rejection;
  • stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

You may not qualify if:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • need for dialysis therapy expected in next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Alicante, Alicante, 03010, Spain

Location

Unknown Facility

Badajoz, Badajoz, 06080, Spain

Location

Unknown Facility

Badalona, Barcelona, 08915, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08003, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08025, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08036, Spain

Location

Unknown Facility

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Unknown Facility

Santander, Cantabria, 39008, Spain

Location

Unknown Facility

Ciudad Real, Ciudad Real, 13005, Spain

Location

Unknown Facility

Córdoba, Cordoba, 14004, Spain

Location

Unknown Facility

Granada, Granada, 18014, Spain

Location

Unknown Facility

A Coruña, La Coruña, 15006, Spain

Location

Unknown Facility

Santiago de Compostela, La Coruña, 15706, Spain

Location

Unknown Facility

Madrid, Madrid, 28007, Spain

Location

Unknown Facility

Madrid, Madrid, 28040, Spain

Location

Unknown Facility

Madrid, Madrid, 28041, Spain

Location

Unknown Facility

Madrid, Madrid, 28222, Spain

Location

Unknown Facility

Valencia, Valencia, 46017, Spain

Location

Unknown Facility

Valladolid, Valladolid, 47005, Spain

Location

Unknown Facility

Barakaldo, Vizcaya, 48903, Spain

Location

Unknown Facility

Galdakao, Vizcaya, 48960, Spain

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

  • Campistol JM, Carreno A, Morales JM, Pallardo L, Franco A, Navarro D, Grinyo JM, Montenegro J, Sanchez Fructuoso AI, Romero R, Guirado L, Arias M; TIVOLI Study Group. Once-monthly pegylated epoetin Beta versus darbepoetin alfa every two weeks in renal transplant recipients: a randomized trial. Transplantation. 2013 Jan 27;95(2):e6-e10. doi: 10.1097/TP.0b013e3182782f3a. No abstract available.

    PMID: 23325012DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfacontinuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

January 18, 2008

First Posted

January 31, 2008

Study Start

December 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 23, 2016

Results First Posted

August 5, 2016

Record last verified: 2016-04

Locations

ES(21)