PDPhase 4NCT01807481
Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD
A Phase 4 study testing Mircera in people with PD, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
The primary objective of study is to evaluate the no of patients which maintain the Hb level between 9.0 ~ 12.0 g/dl during the evaluation period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD
- What is being tested?
- Mircera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Mar 2013to Aug 2015
- 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
- 1.≥18 yr of age
- 2.peritoneal dialysis for ≥12wk before screening and during baseline period
- 3.weekly Kt/V ≥1.8 for PD patients
- 4.Baseline Hb concentration between 9.0 and 12.0g/dl(mean of the monthly Hb values determined in month -2 and -1)
- 5.stable baseline Hb concentration(defined as an absolute difference ≤2g/dl between the Hb values determined in month -2 and -1)
- 6.continuous subcutaneous maintenance epoetin or darbepoetin therapy for at least 2 months before screening and during baseline period
- 7.adequate iron status defined as serum ferritin ≥ 100ng/ml or transferrin saturation≥20%(mean of two values deteremined in month -2 and -1)
Who cannot join
- 1.Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion wihin 2 months before screening during baseline pereiod
- 2.RBC transfusions within 2 months before screening or during baseline period
- 3.nonrenal causes of anemia(e.g folic acid or vitamin B12 deficiency,hemolysis)
- 4.acute infection or chronic, uncontrolled or symptomatic inflammatory disease(e.g rhematoid arthritis,systemic lupus erythematosus)
- 5.C-reactive protein>30mg/dl
- 6.poorly controlled hypertension necessitating interruption of epotien or darbepoetin in the 6 months before screening
Show all 11Show fewer
- 7.platelets > 500X109/L
- 8.pure red cell aplasia
- 9.chronic congestive heart failure(New Yorj Heart Association class IV)
- 10.Myocardial infarction,severe or unstable coronary artery disease,stroke,severe liver disease within the 3months before screening or during baseline
- 11.Life expectancy < 12months
Trial locations and contacts
2 sites in 1 country.
Dae Joong Kim contact
South Korea2 sites, 2 recruiting
- Not yet recruiting
Samsung Medical Center
Seoul, 135-710
Dae Joong Kim
Dae Joong Kim
- Recruiting
Samsung Medical Center
Seoul, 135-710
Dae Joon g Kim
Dae Joong Kim
About this study
Official title: A Prospective,Single-arm,Multicenter Study to Evaluate the Efficacy and Safety of Mircera in Peritoneal Patients Who Already Had Been Treated With ESA
The primary objective of study is to evaluate the no of patients which maintain the Hb level between 9.0 ~ 12.0 g/dl during the evaluation period
Read the detailed description
The secondary objective of study is
- No of patients with mean Hb level of +/-1.0g/dl difference from the baseline Hb
- Incidence of RBC transfusion during the titration and evaluation periods
- Mean Hb during the total study period
- Intrapatient Hb variability (mean within-patient standard deviation for Hb)
- Frequency of Micera dose level
- safety
- Conditions
- PD
- Being tested
- Mircera
- Keywords
- Mircera, PD, Maitenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirceraDrug
Once Monthly Mircera
| Study group | Role | What they receive |
|---|---|---|
| Mircera Arm | Experimental | Once Monthly Mircera Receives: Drug: Mircera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hemoglobin 10~12 g/dl
The primary objective of this study is to evaluate the no of patients which maintain the Hb-level between 10.0~13.0 g/dL during the evaluation period
Measured: Visit 0 ~ visit 10 (10 months)
Secondary outcomes (1)
Hemoglobin stability, Dose adjustment
Incidence of RBC transfusion during the titration and evaluation periods Mean Hb during the total study period Intrapatient Hb variability (mean within patient standard deviations for Hb) Comparison between baseline and evaluation period mean Hb level Frequency of dose adjustments Safety
Measured: Visit0~Visit 10 (10 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Dae Joong, Samsung Medical Center
- Investigators
- Dae Joong Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807481
- Sponsor's protocol ID
- SMC 2011-10-131
- Status last verified
- Jun 2013
- First submitted
- 6 Mar 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Single-arm,Multicenter Study to Evaluate the Efficacy and Safety of Mircera in Peritoneal Patients Who Already Had Been Treated With ESA
- ClinicalTrials.gov ID
- NCT01807481
- Acronym / sponsor ID
- SMC 2011-10-131
- Conditions
- PD
- Keywords
- Mircera, PD, Maitenance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 Mar 2013 (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.
The primary objective of study is to evaluate the no of patients which maintain the Hb level between 9.0 ~ 12.0 g/dl during the evaluation period
Detailed description
The secondary objective of study is
- No of patients with mean Hb level of +/-1.0g/dl difference from the baseline Hb
- Incidence of RBC transfusion during the titration and evaluation periods
- Mean Hb during the total study period
- Intrapatient Hb variability (mean within-patient standard deviation for Hb)
- Frequency of Micera dose level
- safety
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mircera Arm | Experimental | Drug: MirceraOnce Monthly Mircera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.≥18 yr of age
- 2.peritoneal dialysis for ≥12wk before screening and during baseline period
- 3.weekly Kt/V ≥1.8 for PD patients
- 4.Baseline Hb concentration between 9.0 and 12.0g/dl(mean of the monthly Hb values determined in month -2 and -1)
- 5.stable baseline Hb concentration(defined as an absolute difference ≤2g/dl between the Hb values determined in month -2 and -1)
Key exclusion criteria (11 listed)
- 1.Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion wihin 2 months before screening during baseline pereiod
- 2.RBC transfusions within 2 months before screening or during baseline period
- 3.nonrenal causes of anemia(e.g folic acid or vitamin B12 deficiency,hemolysis)
- 4.acute infection or chronic, uncontrolled or symptomatic inflammatory disease(e.g rhematoid arthritis,systemic lupus erythematosus)
- 5.C-reactive protein>30mg/dl
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 |
|---|---|---|
| MirceraOnce Monthly Mircera | Drug | Mircera Arm |
Primary outcome
Number of patients with hemoglobin 10~12 g/dl
Time frame: Visit 0 ~ visit 10 (10 months)
The primary objective of this study is to evaluate the no of patients which maintain the Hb-level between 10.0~13.0 g/dL during the evaluation period
1 secondary outcome
Hemoglobin stability, Dose adjustment
Time frame: Visit0~Visit 10 (10 Months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
Related trials for PD
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
RecruitingPhase 3
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Solid Tumors, Hematologic Malignancies
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.
Dae Joong Kim contact
Dae Joong Kim principal investigator
Samsung Medical Center
2 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 Mircera in people with PD, run by Samsung Medical Center at 2 sites in South Korea.
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 11 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: status not confirmed, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae Joong Kim (82234103441, daejoong.smc.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with hemoglobin 10~12 g/dl (time frame: Visit 0 ~ visit 10 (10 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 12 Jun 2013.