Clinical trial NCT00442416: A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
timeFrame: From Baseline (D 0) to 9 months
Secondary outcomes:
measure: Percentage of Participants With Safety-Related Hb Measures
timeFrame: Up to Month 9
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Month 9
measure: Mean Change From Baseline in Iron
timeFrame: From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8
measure: Mean Change From Baseline in Ferritin
timeFrame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
measure: Mean Change From Baseline in Transferrin Saturation
timeFrame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
measure: Mean Change From Baseline in Serum Transferrin
timeFrame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
measure: Mean Change From Baseline in Total Iron-binding Capacity
timeFrame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
measure: Mean Change From Baseline in Temperature
timeFrame: From Baseline (D 0) to D1 and D15 of M7, M8
measure: Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
timeFrame: From Baseline (D 0) to D1 and D15 of M7, M8
measure: Mean Change From Baseline in Pulse Rate
timeFrame: From Baseline (D 0) to D1 and D15 of M7, M8
measure: Mean Change From Baseline in Weight
timeFrame: From Baseline (D 0) to D1 and D15 of M7, M8
measure: Number of Participants With Anti-erythropoietin Antibody in Human Serum
timeFrame: Up to Month 9
measure: Number of Participants With Anti-RO0503821 Antibody in Human Serum
timeFrame: Up to Month 9
measure: Number of Participants With Any AEs, Any Serious Adverse Events and Death
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Mountain View
country: United States
state: California
city: San Leandro
country: United States
state: California
city: Simi Valley
country: United States
state: California
city: Whittier
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Wichita
country: United States
state: Kansas
city: Detroit
country: United States
state: Michigan
city: Pontiac
country: United States
state: Michigan
city: Flushing
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Lewistown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Dyersburg
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: