Renal Tubular Acidosis, Distal, With Hemolytic AnemiaNCT02490514
A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis
An observational study of Renal Tubular Acidosis, Distal, With Hemolytic Anemia, run by Hoffmann-La Roche at 10 sites in Serbia.
Trial summary
This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Tubular Acidosis, Distal, With Hemolytic Anemia
- Type of treatment
- Injection or infusion
- How many people
- 153 participants
- Where
- 10 sitesSerbia
- Study dates
- Dec 2009to Feb 2012
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 to 75 years old with stage III-IV chronic kidney disease not on dialysis
Who may be able to join
- Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive
- Patients who will not require dialysis within 12 months after the start of Mircera therapy
- Patients whose life expectancy is greater than 12 months after Mircera initiation
- Patients >/= 18 years and </= 75 years of age
- Patients who are female and of childbearing potential must be using effective contraception methods
- Patients with no contra-indications to ESA treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local SmPC)
- Patients who have given written informed consent where local regulations allow or require it
Who cannot join
- Patients with stage I-II or stage V CKD
- Poorly controlled hypertension
- Active malignant disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Serbia10 sites
Study site
Belgrade, 11000
Study site
Ćuprija, 35230
Study site
Kragujevac, 34000
Study site
Niš, 18000
Study site
Pirot, 18300
Study site
Požarevac, 12000
Study site
Šabac, 15000
Study site
Sremska Mitrovica, 22000
Study site
Užice, 31000
Study site
Zrenjanin, 23000
About this study
Official title: Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study
This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.
- Being tested
- No intervention
- Medical subject headings
- Renal Tubular Acidosis, Distal, With Hemolytic Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention was administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Mircera | Patients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment
Measured: 12 months
Secondary outcomes (5)
Hb Levels At Start And End Of Treatment
Measured: 12 months
Mircera Dose At Start And End Of Treatment
Measured: 12 months
Time To Achieve Response To Mircera
Measured: 12 months
Percent Of Participants Treated With Iron Supplements
Measured: 12 months
Percent of Participants Who Required Transfusion At Start And End Of Treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Tubular Acidosis, Distal, With Hemolytic 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
- Observational
- Observational model
- Cohort
- Enrolment
- 153 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
- NCT02490514
- Sponsor's protocol ID
- ML25065
- Status last verified
- Aug 2015
- First submitted
- 2 Jul 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study
- ClinicalTrials.gov ID
- NCT02490514
- Acronym / sponsor ID
- ML25065
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Jul 2015 (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 open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mircera | – | Other: No interventionPatients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 to 75 years old with stage III-IV chronic kidney disease not on dialysis
Key inclusion criteria (7 listed)
- Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive
- Patients who will not require dialysis within 12 months after the start of Mircera therapy
- Patients whose life expectancy is greater than 12 months after Mircera initiation
- Patients >/= 18 years and </= 75 years of age
- Patients who are female and of childbearing potential must be using effective contraception methods
Key exclusion criteria (3 listed)
- Patients with stage I-II or stage V CKD
- Poorly controlled hypertension
- Active malignant disease
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 |
|---|---|---|
| No interventionNo intervention was administered in this study. | Other | Mircera |
Primary outcome
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment
Time frame: 12 months
5 secondary outcomes
Hb Levels At Start And End Of Treatment
Time frame: 12 months
Mircera Dose At Start And End Of Treatment
Time frame: 12 months
Time To Achieve Response To Mircera
Time frame: 12 months
Percent Of Participants Treated With Iron Supplements
Time frame: 12 months
Percent of Participants Who Required Transfusion At Start And End Of Treatment
Time frame: 12 months
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 Aug 2015.
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RecruitingObservational study
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Tubular Acidosis, Distal, With Hemolytic Anemia, run by Hoffmann-La Roche at 10 sites in Serbia.
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 7 inclusion and 3 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Serbia. 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.
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?
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment (time frame: 12 months). 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 Aug 2015.