AnemiaPhase 3NCT00605345
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
A Phase 3 study testing Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 21 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 21 sitesSpain
- Study dates
- Dec 2007to Jul 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Study site
A Coruña, La Coruña, 15006
Study site
Alicante, Alicante, 03010
Study site
Badajoz, Badajoz, 06080
Study site
Badalona, Barcelona, 08915
Study site
Barakaldo, Vizcaya, 48903
Study site
Barcelona, Barcelona, 08003
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08036
Study site
Ciudad Real, Ciudad Real, 13005
Study site
Córdoba, Cordoba, 14004
Study site
Galdakao, Vizcaya, 48960
Study site
Granada, Granada, 18014
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28222
Study site
Santander, Cantabria, 39008
Study site
Santiago de Compostela, La Coruña, 15706
Study site
Valencia, Valencia, 46017
Study site
Valladolid, Valladolid, 47005
About this study
Official title: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.
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.
- Conditions
- Anemia
- Being tested
- Darbepoetin alfa, 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.
Darbepoetin alfaDrug
As prescribed
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
120, 200 or 360 micrograms sc 4-weekly (starting dose)
| Study group | Role | What they receive |
|---|---|---|
| CERA Treatment Once Monthly | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Darbepoetin Alfa Once Biweekly | Active comparator | Not described Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 16-28
Secondary outcomes (5)
Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)
Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.
Measured: Baseline to 28 weeks
Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)
Measured: Weeks 16-28
Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)
Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.
Measured: Weeks 16-28
Percentage of Participants Needing Dose Adjustments
Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).
Measured: Up to 28 weeks
Incidence of RBC Transfusions
Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJul 2009
- Study completionJul 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605345
- Sponsor's protocol ID
- ML21058
- Status last verified
- Apr 2016
- First submitted
- 18 Jan 2008
- Last updated
- 23 Sep 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 36791280Campistol 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.
PubMed 23325012
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.
- ClinicalTrials.gov ID
- NCT00605345
- Acronym / sponsor ID
- ML21058
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 5 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CERA Treatment Once Monthly | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Darbepoetin Alfa Once Biweekly | Active comparator | Drug: Darbepoetin alfa |
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, > 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Darbepoetin alfaAs prescribed | Drug | Darbepoetin Alfa Once Biweekly |
| methoxy polyethylene glycol-epoetin beta [Mircera]120, 200 or 360 micrograms sc 4-weekly (starting dose) | Drug | CERA Treatment Once Monthly |
Primary outcome
The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range
Time frame: Weeks 16-28
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.
5 secondary outcomes
Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)
Time frame: Baseline to 28 weeks
Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)
Time frame: Weeks 16-28
Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)
Time frame: Weeks 16-28
Percentage of Participants Needing Dose Adjustments
Time frame: Up to 28 weeks
Incidence of RBC Transfusions
Time frame: Up to 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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 23325012Campistol 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.
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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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 21 sites in Spain.
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 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. 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 5 Aug 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?
The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (time frame: Weeks 16-28). 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 NCT00605345, 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 23 Sep 2016.