Clinical trial NCT00462384: A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.
Official title: An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram \[mcg/kg\]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* chronic kidney disease, stage 3 or 4;
* anemia (baseline hemoglobin between 9 and 11 grams per deciliter \[g/dL\]).

Exclusion Criteria:

* previous therapy with ESA within 12 weeks prior to screening;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* red blood cell transfusions within 8 weeks before screening;
* active malignant disease (except non-melanoma skin cancer).

Primary outcomes:
measure: Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
timeFrame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)
Secondary outcomes:
measure: Time to Achievement of Response
timeFrame: Baseline to Week 40
measure: Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
timeFrame: EEP (Weeks 29 to 36)
measure: Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
timeFrame: EEP (Weeks 29 to 36)
measure: Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
timeFrame: EEP (Weeks 29 to 36)
Other outcomes:
Locations:
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: HUS
country: Finland
city: Joensuu
country: Finland
city: Jyväskylä
country: Finland
city: Kajaani
country: Finland
city: Kotka
country: Finland
city: Porvoo
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Jurmala
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Ventspils
country: Latvia
city: Honefoss
country: Norway
city: Lillehammer
country: Norway
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Trondheim
country: Norway
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: