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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Epoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
  • California
    • Bakersfield, California, United States, 93309
    • Chula Vista, California, United States, 91910
    • Mountain View, California, United States, 94041
    • San Leandro, California, United States, 94578
    • Simi Valley, California, United States, 93065
    • Whittier, California, United States, 90602
  • Colorado
    • Lakewood, Colorado, United States, 80214
  • Connecticut
    • Stamford, Connecticut, United States, 06902
  • Florida
    • Ocala, Florida, United States, 34471
    • Pembroke Pines, Florida, United States, 33028
  • Georgia
    • Augusta, Georgia, United States, 30901
    • Marietta, Georgia, United States, 30060
  • Kansas
    • Wichita, Kansas, United States, 67214
  • Michigan
    • Detroit, Michigan, United States, 48236
    • Pontiac, Michigan, United States, 48341
  • New York
    • Flushing, New York, United States, 11355
    • Syracuse, New York, United States, 13212
    • Williamsville, New York, United States, 14221
  • Ohio
    • Dayton, Ohio, United States, 45408
    • Toledo, Ohio, United States, 43606
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74120
  • Pennsylvania
    • Lewistown, Pennsylvania, United States, 17044
    • Philadelphia, Pennsylvania, United States, 19106
  • Tennessee
    • Dyersburg, Tennessee, United States, 38024
  • Texas
    • San Antonio, Texas, United States, 78215
    • Tyler, Texas, United States, 75701
  • Virginia
    • Alexandria, Virginia, United States, 22304
    • Richmond, Virginia, United States, 23229

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period	Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.	From Baseline (D 0) to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Safety-Related Hb Measures	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.	Up to Month 9
Number of Participants With Marked Laboratory Abnormalities	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.	Up to Month 9
Mean Change From Baseline in Iron	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.	From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Ferritin	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.	From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Transferrin Saturation	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.	From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Serum Transferrin	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.	From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Total Iron-binding Capacity	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.	From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Temperature		From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure		From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Pulse Rate		From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Weight		From Baseline (D 0) to D1 and D15 of M7, M8
Number of Participants With Anti-erythropoietin Antibody in Human Serum	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.	Up to Month 9
Number of Participants With Anti-RO0503821 Antibody in Human Serum	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.	Up to Month 9
Number of Participants With Any AEs, Any Serious Adverse Events and Death	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.	Up to 9 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): January 1, 2008
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: March 1, 2007
• First Submitted That Met QC Criteria: March 1, 2007
• First Posted (ESTIMATE): March 2, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2016
• Last Update Submitted That Met QC Criteria: July 5, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML20338