Clinical trial NCT02538107: An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant
Official title: Non-interventional, Observational Study to Investigate the Efficiency and Safety of Mircera in Patients With a Kidney Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with kidney transplant prescribed methoxy polyethyleneglycol-epoetin beta

Brief summary: This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collected over 15 months of Mircera therapy.


Eligibility criteria: Inclusion Criteria:

* Participants with kidney transplant and a chronic kidney disease (CKD), who need erythropoiesis stimulating agent (ESA) therapy as part of their medical care and prescribed methoxy polyethyleneglycol-epoetin beta by the doctor.
* The transplant should function regularly and without need of continuous dialysis treatment at inclusion and also during the documentation period of this study according to treating physician's prognosis.

Exclusion Criteria:

* Kidney transplantation dates back less than 3 months. Acute decrease of hemoglobin (Hb) before enrollment, defined as decrease of greater than or equal to (\>/=) 2 g/dL between two sequential values.
* Administration of other ESA therapies during the observation period.

Primary outcomes:
measure: 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)
timeFrame: From Month 7 to Month 9
measure: Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)
timeFrame: From Month 7 to Month 9
measure: Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
timeFrame: From Month 7 to Month 12
measure: Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
timeFrame: From Month 7 to Month 15
measure: Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
timeFrame: From Month 7 to Month 12
measure: Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
timeFrame: From Month 7 to Month 15
measure: Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment
timeFrame: Up to 50 months
Secondary outcomes:
measure: Hemoglobin Level Based on the Type of Kidney Transplantation Performed
timeFrame: 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)
measure: Hemoglobin Level Based on the Presence of Inflammatory Diseases
timeFrame: 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)
measure: Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
timeFrame: 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)
measure: Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
timeFrame: 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)
measure: Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
timeFrame: 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)
Other outcomes:
Locations:
city: Hann. Münden
country: Germany
facility: Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: