AnemiaPhase 4NCT01191983
A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
A Phase 4 study testing Methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 14 sites in India.
Trial summary
This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. 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]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 14 sitesIndia
- Study dates
- 13 Aug 2010to 23 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Diabetic nephropathy
- Chronic renal anemia with stage III-IV CKD
- Not on dialysis and not expected to require dialysis within the next 6 months
- Not receiving any ESA in the 2 months prior to study
- Adequate iron status
Who cannot join
- Transfusion of red blood cells during the previous 2 months
- Known or clinical suspicion of pure red cell aplasia
- Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Haemoglobinopathy
- Significant acute or chronic bleeding
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
India14 sites
Vijayratna Diabetes Diagnosis & Treatment Center
Ahmedabad, 380007
M S Ramaiah Memorial Hospital
Bangalore, 560054
North Delhi Diabetes Centre
Delhi, 110085
MAX Balaji Hospital
Delhi, 110092
Osmania General Hospital; Department of Nephrology
Hyderabad, Andhra Pradesh, 500012
Dr.Modi's Clinic
Hyderabad, 500001
IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre
Kolkata, 700 020
Apex Kidney Care Pvt. Ltd., Sushrut Hospital
Mumbai, 400 071
Diab Care Centre
Mumbai, 400076
Sanjeevani Hospital
Mumbai, 400097
Pushpawati Singhania Research Institute; Nephrology
New Delhi, National Capital Territory of Delhi, 110017
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Sahyadri Speciality Hospital
Pune, 411004
Diabetes Care & Research Centre
Pune, 411011
About this study
Official title: A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.
This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.
- 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
Also called Mircera, C.E.R.A
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
| Study group | Role | What they receive |
|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Experimental | Participants will receive 1.2 mcg/kg methoxy polyethylene glycol-epoetin beta given in monthly doses at each visit. Dose will be measured on the basis of the participants Hb level during the study period. The dose administration will be the nearest possible dose using the prefilled syringes containing 50, 75 and 100 mcg/kg Q4W. 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.
Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)
Measured: EEP (Week 17 up to Week 24)
Change in Hb Concentration Between Baseline and EEP
Measured: Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24)
Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP
Measured: EEP: (Week 17 up to Week 24)
Secondary outcomes (4)
Percentage of Participants With Adverse Events
Measured: Baseline (Week -2 up to Week 0) to Week 28
Percentage of Participants With Red Blood Cell Transfusion During Treatment Period
Measured: Week 0 up to Week 24
Percentage of Participants with anti-epoetin antibodies
Measured: Baseline (Week-2 up to Week 0) up to Week 28
Short Form-36 Health Survey (SF-36) score
Measured: Week 0 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study start13 Aug 2010
- Primary completion23 Apr 2018
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT01191983
- Sponsor's protocol ID
- ML25276
- Status last verified
- Jul 2018
- First submitted
- 16 Aug 2010
- Last updated
- 18 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.
- ClinicalTrials.gov ID
- NCT01191983
- Acronym / sponsor ID
- ML25276
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2010 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Experimental | Drug: Methoxy polyethylene glycol-epoetin beta [Mircera]Participants will receive 1.2 mcg/kg methoxy polyethylene glycol-epoetin beta given in monthly doses at each visit. Dose will be measured on the basis of the participants Hb level during the study period. The dose administration will be the nearest possible dose using the prefilled syringes containing 50, 75 and 100 mcg/kg Q4W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetic nephropathy
- Chronic renal anemia with stage III-IV CKD
- Not on dialysis and not expected to require dialysis within the next 6 months
- Not receiving any ESA in the 2 months prior to study
- Adequate iron status
Key exclusion criteria (5 listed)
- Transfusion of red blood cells during the previous 2 months
- Known or clinical suspicion of pure red cell aplasia
- Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Haemoglobinopathy
- Significant acute or chronic bleeding
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]Also: Mircera, C.E.R.AStarting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W | Drug | Methoxy polyethylene glycol-epoetin beta |
Primary outcome
Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)
Time frame: EEP (Week 17 up to Week 24)
Change in Hb Concentration Between Baseline and EEP
Time frame: Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24)
Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP
Time frame: EEP: (Week 17 up to Week 24)
4 secondary outcomes
Percentage of Participants With Adverse Events
Time frame: Baseline (Week -2 up to Week 0) to Week 28
Percentage of Participants With Red Blood Cell Transfusion During Treatment Period
Time frame: Week 0 up to Week 24
Percentage of Participants with anti-epoetin antibodies
Time frame: Baseline (Week-2 up to Week 0) up to Week 28
Short Form-36 Health Survey (SF-36) score
Time frame: Week 0 to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 14 sites in India.
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 5 inclusion and 5 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP) (time frame: EEP (Week 17 up to Week 24)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2018.