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An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant

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ClinicalTrials.gov Identifier: NCT02538107
Recruitment Status : Completed
First Posted : September 2, 2015
Results First Posted : November 3, 2015
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Anemia, Kidney Transplantation Drug: Methoxy-polyethyleneglycol epoetin beta

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Study Type : Observational
Actual Enrollment : 290 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Observational Study to Investigate the Efficiency and Safety of Mircera in Patients With a Kidney Transplant
Actual Study Start Date : September 30, 2007
Actual Primary Completion Date : November 30, 2011
Actual Study Completion Date : November 30, 2011


Group/Cohort Intervention/treatment
Kidney Transplant Participants
Participants with kidney transplant and a chronic kidney disease who were receiving methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care.
Drug: Methoxy-polyethyleneglycol epoetin beta
Other Name: Mircera




Primary Outcome Measures :
  1. 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) [ Time Frame: From Month 7 to Month 9 ]
  2. Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) [ Time Frame: From Month 7 to Month 9 ]
  3. Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) [ Time Frame: From Month 7 to Month 12 ]
  4. Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) [ Time Frame: From Month 7 to Month 15 ]
  5. Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) [ Time Frame: From Month 7 to Month 12 ]
  6. Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) [ Time Frame: From Month 7 to Month 15 ]
  7. Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment [ Time Frame: Up to 50 months ]

Secondary Outcome Measures :
  1. Hemoglobin Level Based on the Type of Kidney Transplantation Performed [ Time Frame: 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.

  2. Hemoglobin Level Based on the Presence of Inflammatory Diseases [ Time Frame: 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.

  3. Hemoglobin Level Based on the Etiology of Chronic Kidney Disease [ Time Frame: 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.

  4. Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study [ Time Frame: 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 in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes.

  5. Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) [ Time Frame: 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) ]
    GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with kidney transplant prescribed methoxy polyethyleneglycol-epoetin beta
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538107


Locations
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Germany
Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen
Hann. Münden, Germany, 34346
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02538107     History of Changes
Other Study ID Numbers: ML21386
First Posted: September 2, 2015    Key Record Dates
Results First Posted: November 3, 2015
Last Update Posted: June 7, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Epoetin Alfa
Hematinics