Trial Outcomes & Findings for OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis (NCT NCT01902628)
NCT ID: NCT01902628
Last Updated: 2019-08-09
Results Overview
g/dL = grams per deciliter
Recruitment status
COMPLETED
Target enrollment
437 participants
Primary outcome timeframe
Months 8 to 10
Results posted on
2019-08-09
Participant Flow
Participant milestones
| Measure |
Participants With CKD
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
437
|
|
Overall Study
COMPLETED
|
354
|
|
Overall Study
NOT COMPLETED
|
83
|
Reasons for withdrawal
| Measure |
Participants With CKD
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Overall Study
Withdrawal of participant's consent
|
7
|
|
Overall Study
Adverse Event
|
41
|
|
Overall Study
Lost to Follow-up
|
35
|
Baseline Characteristics
OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis
Baseline characteristics by cohort
| Measure |
Participants With CKD
n=437 Participants
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Age, Continuous
|
76 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 8 to 10Population: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.
g/dL = grams per deciliter
Outcome measures
| Measure |
Participants With CKD
n=437 Participants
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
|
51.2 percentage of participants
|
SECONDARY outcome
Timeframe: Months 8 to 10Population: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.
g/dL = grams per deciliter
Outcome measures
| Measure |
Participants With CKD
n=437 Participants
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10
10.0 - 13.0 g/dL
|
68.8 percentage of participants
|
|
Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10
11.0 - 12.0 g/dL
|
35.4 percentage of participants
|
|
Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10
11.0 - 13.0 g/dL
|
53 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. Number analyzed indicates number of participants evaluated at specific time points.
Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.
Outcome measures
| Measure |
Participants With CKD
n=437 Participants
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Percentage of Participants With MIRCERA Dose Adjustments
1 Month, Dose Decreased
|
13 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
2 Months, Dose Decreased
|
12.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
3 Months, Dose Decreased
|
10.6 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
4 Months, Dose Decreased
|
11 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
5 Months, Dose Decreased
|
11.6 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
6 Months, Dose Decreased
|
10.2 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
7 Months, Dose Decreased
|
10.2 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
8 Months, Dose Decreased
|
9.6 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
9 Months, Dose Decreased
|
8.2 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
10 Months, Dose Decreased
|
8.2 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
1 Month, Same Dose
|
58 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
2 Months, Same Dose
|
54 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
3 Months, Same Dose
|
54.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
4 Months, Same Dose
|
50.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
5 Months, Same Dose
|
53.8 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
6 Months, Same Dose
|
51 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
7 Months, Same Dose
|
54.6 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
8 Months, Same Dose
|
55.8 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
9 Months, Same Dose
|
60 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
10 Months, Same Dose
|
59.6 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
1 Month, Dose Increased
|
18.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
2 Months, Dose Increased
|
14.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
3 Months, Dose Increased
|
12.8 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
4 Months, Dose Increased
|
12.8 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
5 Months, Dose Increased
|
10.6 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
6 Months, Dose Increased
|
14.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
7 Months, Dose Increased
|
10.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
8 Months, Dose Increased
|
9.2 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
9 Months, Dose Increased
|
9.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
10 Months, Dose Increased
|
11.2 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
1 Month, Data Not Reported
|
10.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
2 Months, Data Not Reported
|
19.2 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
3 Months, Data Not Reported
|
22.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
4 Months, Data Not Reported
|
25.8 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
5 Months, Data Not Reported
|
24 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
6 Months, Data Not Reported
|
24.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
7 Months, Data Not Reported
|
24.8 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
8 Months, Data Not Reported
|
25.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
9 Months, Data Not Reported
|
22.4 percentage of participants
|
|
Percentage of Participants With MIRCERA Dose Adjustments
10 Months, Data Not Reported
|
21 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.
Outcome measures
| Measure |
Participants With CKD
n=437 Participants
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
Serious AEs
|
56 Participants
|
|
Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
Non-Serious AEs
|
37 Participants
|
Adverse Events
Participants With CKD
Serious events: 56 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With CKD
n=437 participants at risk
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
6/437 • Up to 10 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.23%
1/437 • Up to 10 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.23%
1/437 • Up to 10 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.23%
1/437 • Up to 10 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.23%
1/437 • Up to 10 months
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/437 • Up to 10 months
|
|
Cardiac disorders
Aortic valve incompetence
|
0.23%
1/437 • Up to 10 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.23%
1/437 • Up to 10 months
|
|
Cardiac disorders
Cardiac arrest
|
0.69%
3/437 • Up to 10 months
|
|
Cardiac disorders
Cardiac failure
|
0.23%
1/437 • Up to 10 months
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.23%
1/437 • Up to 10 months
|
|
Cardiac disorders
Myocardial infarction
|
0.46%
2/437 • Up to 10 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
1/437 • Up to 10 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.23%
1/437 • Up to 10 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.46%
2/437 • Up to 10 months
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.23%
1/437 • Up to 10 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
1/437 • Up to 10 months
|
|
General disorders
Death
|
0.69%
3/437 • Up to 10 months
|
|
General disorders
General physical health deterioration
|
0.23%
1/437 • Up to 10 months
|
|
General disorders
Pyrexia
|
0.46%
2/437 • Up to 10 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.46%
2/437 • Up to 10 months
|
|
Infections and infestations
Gastroenteritis
|
0.46%
2/437 • Up to 10 months
|
|
Infections and infestations
H1N1 influenza
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Lung infection
|
0.46%
2/437 • Up to 10 months
|
|
Infections and infestations
Pneumonia
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Sepsis
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Urinary tract infection
|
0.23%
1/437 • Up to 10 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/437 • Up to 10 months
|
|
Investigations
Blood creatinine increased
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/437 • Up to 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.23%
1/437 • Up to 10 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
1/437 • Up to 10 months
|
|
Nervous system disorders
Syncope
|
0.23%
1/437 • Up to 10 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.69%
3/437 • Up to 10 months
|
|
Renal and urinary disorders
Glomerulosclerosis
|
0.23%
1/437 • Up to 10 months
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
6/437 • Up to 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
3/437 • Up to 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.23%
1/437 • Up to 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.23%
1/437 • Up to 10 months
|
|
Surgical and medical procedures
Haemodialysis
|
0.23%
1/437 • Up to 10 months
|
|
Surgical and medical procedures
Peritoneal dialysis
|
0.23%
1/437 • Up to 10 months
|
|
Vascular disorders
Shock
|
0.23%
1/437 • Up to 10 months
|
|
Vascular disorders
Thrombosis
|
0.23%
1/437 • Up to 10 months
|
Other adverse events
| Measure |
Participants With CKD
n=437 participants at risk
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/437 • Up to 10 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.46%
2/437 • Up to 10 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.23%
1/437 • Up to 10 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/437 • Up to 10 months
|
|
General disorders
Catheter site injury
|
0.23%
1/437 • Up to 10 months
|
|
General disorders
Oedema peripheral
|
0.23%
1/437 • Up to 10 months
|
|
General disorders
Pyrexia
|
0.46%
2/437 • Up to 10 months
|
|
Infections and infestations
Bronchitis
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Chlamydial infection
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Cystitis
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Influenza
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Respiratory tract infection
|
0.69%
3/437 • Up to 10 months
|
|
Infections and infestations
Rhinitis
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Testicular abscess
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Tooth abscess
|
0.23%
1/437 • Up to 10 months
|
|
Infections and infestations
Urinary tract infection
|
1.6%
7/437 • Up to 10 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.23%
1/437 • Up to 10 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.23%
1/437 • Up to 10 months
|
|
Investigations
International normalised ratio increased
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.23%
1/437 • Up to 10 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.23%
1/437 • Up to 10 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.23%
1/437 • Up to 10 months
|
|
Nervous system disorders
Headache
|
0.23%
1/437 • Up to 10 months
|
|
Nervous system disorders
Tremor
|
0.23%
1/437 • Up to 10 months
|
|
Psychiatric disorders
Depression
|
0.23%
1/437 • Up to 10 months
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.23%
1/437 • Up to 10 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.46%
2/437 • Up to 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.46%
2/437 • Up to 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/437 • Up to 10 months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.23%
1/437 • Up to 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.23%
1/437 • Up to 10 months
|
|
Surgical and medical procedures
Haemodialysis
|
0.23%
1/437 • Up to 10 months
|
|
Surgical and medical procedures
Oral surgery
|
0.23%
1/437 • Up to 10 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.23%
1/437 • Up to 10 months
|
|
Vascular disorders
Hypertension
|
0.46%
2/437 • Up to 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER