Trial · NCT02538107
An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant
NCT02538107, Completed, Hoffmann-La Roche; results first posted 2015-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant. Trials, record NCT02538107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02538107
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant
- NCT number
- NCT02538107
- Status
- Completed
- Enrollment
- 290 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Anemia, Kidney Transplantation
- Interventions
- Methoxy-polyethyleneglycol epoetin beta
- First posted
- 2015-09-02
- Last updated
- 2017-06-07
- Results first posted
- 2015-11-03
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 | |
| Primary | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 | |
| Primary | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 | |
| Primary | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | From Month 7 to Month 15 | |
| Primary | Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 | |
| Primary | Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | From Month 7 to Month 15 | |
| Primary | Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment | Up to 50 months | |
| Secondary | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation. |
| Secondary | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases. |
| Secondary | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 | Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits \[Visits 7-9\]). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 | Efficacy analysis set. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 | Efficacy analysis set. Participants who were evaluable at the specified time frame were included. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | From Month 7 to Month 15 | Efficacy analysis set. Participants who were evaluable at the specified time frame were included. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 | Efficacy analysis set. Participants who were evaluable at the specified time frame were included. | percentage of participants | NUMBER |
| SECONDARY | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Efficacy analysis set. n = number of participants who were evaluable at a particular visit. | g/dL | MEAN |
| SECONDARY | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Efficacy analysis set. n = number of participants who were evaluable at a particular visit. | g/dL | MEAN |
| SECONDARY | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit. | g/dL | MEAN |
| SECONDARY | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit. | g/dL | MEAN |
| SECONDARY | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit. | g/dL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group151
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) | Kidney Transplant Participants | 20.7 | percentage of participants | ||
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) | Kidney Transplant Participants | 40.4 | percentage of participants | ||
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | Kidney Transplant Participants | 21.2 | percentage of participants | ||
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | Kidney Transplant Participants | 12.2 | percentage of participants | ||
| Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | Kidney Transplant Participants | 52.6 | percentage of participants | ||
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Living Donation-Kidney Transplant Participants | Visit 1 (Month 1) (n=22, 113) | 11.08 | Standard Deviation 1.244 | g/dL |
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Cadaveric Donation-Kidney Transplant Participants | Visit 1 (Month 1) (n=22, 113) | 11.26 | Standard Deviation 1.126 | g/dL |
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Living Donation-Kidney Transplant Participants | Visit 2 (Month 2) (n=25, 118) | 11.37 | Standard Deviation 1.215 | g/dL |
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Cadaveric Donation-Kidney Transplant Participants | Visit 2 (Month 2) (n=25, 118) | 11.41 | Standard Deviation 1.239 | g/dL |
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Living Donation-Kidney Transplant Participants | Visit 3 (Month 3) (n=27, 128) | 11.34 | Standard Deviation 1.163 | g/dL |
1 to 10 of 151Source ClinicalTrials.gov
See all 151 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Kidney Transplant Participants | 290 | |
| Overall Study | COMPLETED | Kidney Transplant Participants | 180 | |
| Overall Study | NOT COMPLETED | Kidney Transplant Participants | 110 |
Source ClinicalTrials.gov
Adverse events117
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 | Bone marrow failure | Blood and lymphatic system disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Haemolytic anaemia | Blood and lymphatic system disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Macrocytosis | Blood and lymphatic system disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Palpitations | Cardiac disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Tinnitus | Ear and labyrinth disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Tympanic membrane disorder | Ear and labyrinth disorders | Kidney Transplant Participants | 1 | 279 | |
| other | Vertigo | Ear and labyrinth disorders | Kidney Transplant Participants | 1 | 279 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Kidney Transplant Participants | ||
| Total, other adverse events | Kidney Transplant Participants | 42 | 279 |
| Total, serious adverse events | Kidney Transplant Participants | 32 | 279 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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