Trial · NCT00077610
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
NCT00077610, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-02-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients. Trials, record NCT00077610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00077610
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
- NCT number
- NCT00077610
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 673 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Anemia
- Interventions
- Epoetin alfa or beta, RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks)
- First posted
- 2004-02-13
- Last updated
- 2017-01-13
- Results first posted
- 2016-02-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period | Baseline, Week 29 to Week 36 | A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm. |
| Secondary | Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration. | Baseline, Week 29 to Week 36 | The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. |
| Secondary | The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | Week 1 to Week 36 | The number of participants who received RBC transfusions during the titration and evaluation periods were reported . |
| Secondary | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC) | Up to Week 53 | Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10\^9/Litre \[L\], for WBC was 3.0-18.0.0x10\^9/L, and for RBC was 3.80-6.10x10\^12/L. |
| Secondary | Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes | Up to Week 53 | Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre \[U/L\]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin \>=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre \[mmol/L\]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L |
| Secondary | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Baseline, Week 36 and Week 52 | Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD). |
| Secondary | Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 | Baseline, Week 36 and Week 52 | Change in pulse rate (beats per minute \[bpm\]) from baseline values includes only those participants with both a baseline value and a value for specified time period. |
| Secondary | Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death | Upto Week 53 | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period | Baseline, Week 29 to Week 36 | The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to Hb parameters and \<5 recorded Hb values during the evaluation period with missing administrations of the study drug/ reference drug. Please refer to the outcome measure description section for more details. | gram per deciliter (g/dL) | MEAN |
| SECONDARY | Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration. | Baseline, Week 29 to Week 36 | The intent-to-treat (ITT) population was defined as all randomized participants. At the end of Week 36, data allowing the evaluation of the therapeutic response was available for 196/221, 188/220, and 205/225 participants in RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks), and Epoetin (1 -3x/Weeks), respectively. | participants | NUMBER |
| SECONDARY | The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | Week 1 to Week 36 | The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. | participants | NUMBER |
| SECONDARY | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC) | Up to Week 53 | The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n). | participants | NUMBER |
| SECONDARY | Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes | Up to Week 53 | The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n). | participants | NUMBER |
| SECONDARY | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Baseline, Week 36 and Week 52 | The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n). | millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 | Baseline, Week 36 and Week 52 | The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n). | beats per minute (bpm) | MEAN |
| SECONDARY | Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death | Upto Week 53 | The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period | RO0503821 (1x/2 Weeks) | -0.10 | Standard Deviation 1.06 | gram per deciliter (g/dL) | |
| Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period | RO0503821 (1x/4 Weeks) | 0.01 | Standard Deviation 0.96 | gram per deciliter (g/dL) | |
| Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period | Epoetin (1-3x/Week) | -0.10 | Standard Deviation 0.92 | gram per deciliter (g/dL) | |
| Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration. | RO0503821 (1x/2 Weeks) | 133 | participants | ||
| Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration. | RO0503821 (1x/4 Weeks) | 127 | participants | ||
| Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration. | Epoetin (1-3x/Weeks) | 138 | participants | ||
| The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | RO0503821 (1x/2 Weeks) | 21 | participants | ||
| The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | RO0503821 (1x/4 Weeks) | 16 | participants | ||
| The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | Epoetin (1-3x/Weeks) | 17 | participants | ||
| Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC) | RO0503821 (1x/2 Weeks) | High Platelet (n=218, 216, 223) | 0 | participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RO0503821 (1x/2 Weeks) | 223 | |
| Overall Study | STARTED | RO0503821 (1x/4 Weeks) | 224 | |
| Overall Study | STARTED | Epoetin (1-3x/Weeks) | 226 | |
| Overall Study | Started Treatment | RO0503821 (1x/2 Weeks) | 221 | |
| Overall Study | Started Treatment | RO0503821 (1x/4 Weeks) | 220 | |
| Overall Study | Started Treatment | Epoetin (1-3x/Weeks) | 225 | |
| Overall Study | COMPLETED | RO0503821 (1x/2 Weeks) | 169 | |
| Overall Study | COMPLETED | RO0503821 (1x/4 Weeks) | 168 | |
| Overall Study | COMPLETED | Epoetin (1-3x/Weeks) | 180 | |
| Overall Study | NOT COMPLETED | RO0503821 (1x/2 Weeks) | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events894
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | RO0503821 (1x/2 Weeks) | 24 | 221 | |
| other | Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | RO0503821 (1x/4 Weeks) | 23 | 220 | |
| other | Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | Epoetin (1-3x/Weeks) | 28 | 225 | |
| other | Fall | Injury, poisoning and procedural complications | RO0503821 (1x/2 Weeks) | 15 | 221 | |
| other | Fall | Injury, poisoning and procedural complications | RO0503821 (1x/4 Weeks) | 19 | 220 | |
| other | Fall | Injury, poisoning and procedural complications | Epoetin (1-3x/Weeks) | 15 | 225 | |
| other | Procedural hypotension | Injury, poisoning and procedural complications | RO0503821 (1x/2 Weeks) | 18 | 221 | |
| other | Procedural hypotension | Injury, poisoning and procedural complications | RO0503821 (1x/4 Weeks) | 20 | 220 | |
| other | Procedural hypotension | Injury, poisoning and procedural complications | Epoetin (1-3x/Weeks) | 9 | 225 | |
| other | Arteriovenous fistula site complication | Injury, poisoning and procedural complications | RO0503821 (1x/2 Weeks) | 16 | 221 |
1 to 10 of 894Source ClinicalTrials.gov
See all 894 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RO0503821 (1x/2 Weeks) | ||
| Total, all-cause mortality | RO0503821 (1x/4 Weeks) | ||
| Total, all-cause mortality | Epoetin (1-3x/Weeks) | ||
| Total, other adverse events | RO0503821 (1x/2 Weeks) | 166 | 221 |
| Total, other adverse events | RO0503821 (1x/4 Weeks) | 151 | 220 |
| Total, other adverse events | Epoetin (1-3x/Weeks) | 175 | 225 |
| Total, serious adverse events | RO0503821 (1x/2 Weeks) | 101 | 221 |
| Total, serious adverse events | RO0503821 (1x/4 Weeks) | 87 | 220 |
| Total, serious adverse events | Epoetin (1-3x/Weeks) | 99 | 225 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00077610
GET https://conductscience.org/api/trials/v1/NCT00077610/results?page=2