A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

This study has been terminated.
(Strategic decision unrelated to safety or efficacy)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00442416
First received: March 1, 2007
Last updated: July 5, 2016
Last verified: July 2016
  Purpose
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.

Condition Intervention Phase
Anemia
Drug: Epoetin alfa
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-arm, Randomized, Open-label, Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period [ Time Frame: From Baseline (D 0) to 9 months ] [ Designated as safety issue: No ]
    Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.


Secondary Outcome Measures:
  • Percentage of Participants With Safety-Related Hb Measures [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.

  • Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.

  • Mean Change From Baseline in Iron [ Time Frame: From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8 ] [ Designated as safety issue: No ]
    Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.

  • Mean Change From Baseline in Ferritin [ Time Frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 ] [ Designated as safety issue: No ]
    Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

  • Mean Change From Baseline in Transferrin Saturation [ Time Frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 ] [ Designated as safety issue: No ]
    Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

  • Mean Change From Baseline in Serum Transferrin [ Time Frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 ] [ Designated as safety issue: No ]
    Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

  • Mean Change From Baseline in Total Iron-binding Capacity [ Time Frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 ] [ Designated as safety issue: No ]
    Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

  • Mean Change From Baseline in Temperature [ Time Frame: From Baseline (D 0) to D1 and D15 of M7, M8 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure [ Time Frame: From Baseline (D 0) to D1 and D15 of M7, M8 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Pulse Rate [ Time Frame: From Baseline (D 0) to D1 and D15 of M7, M8 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Weight [ Time Frame: From Baseline (D 0) to D1 and D15 of M7, M8 ] [ Designated as safety issue: No ]
  • Number of Participants With Anti-erythropoietin Antibody in Human Serum [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were "below the limit of quantification (BLQ)" at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.

  • Number of Participants With Anti-RO0503821 Antibody in Human Serum [ Time Frame: Up to Month 9 ] [ Designated as safety issue: No ]
    RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were "BLQ" at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.

  • Number of Participants With Any AEs, Any Serious Adverse Events and Death [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.


Enrollment: 80
Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO0503821
Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so.
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120-360 micrograms SC monthly, starting dose
Active Comparator: Epoetin Alfa
Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.
Drug: Epoetin alfa
As prescribed, SC

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic kidney disease stage V;
  • on peritoneal dialysis for 3 months prior to screening;
  • on epoetin alfa sc >=3 months prior to screening.

Exclusion Criteria:

  • patients expecting to change dialysis modality over course of study;
  • patients hospitalized during previous 3 months for any clinically significant condition;
  • active malignancy;
  • bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
  • transfusion of red blood cells within 3 months prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442416

  Show 29 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00442416     History of Changes
Other Study ID Numbers: ML20338 
Study First Received: March 1, 2007
Results First Received: July 5, 2016
Last Updated: July 5, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on August 22, 2016