Clinical trial NCT00869856: Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
Official title: An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Anemia
Chronic Renal Insufficiency
Keywords: Treatment associated with CRI
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.

Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.


Eligibility criteria: Inclusion Criteria:

* Male and female CKD subjects with or without dialysis treatment
* Age \> 18 years
* Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
* Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
* Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
* Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4

Exclusion Criteria:

* Systemic cyclosporine
* History of PRCA or aplastic anemia
* History of anti-EPO antibodies
* Uncontrolled hypertension

Primary outcomes:
measure: Change in hemoglobin level
timeFrame: 36 weeks
Secondary outcomes:
measure: To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Gabrovo
country: Bulgaria
facility: MHAT "Dr. Tota Venkova"
city: Pazardzhik
country: Bulgaria
facility: MHAT Pazardzhik
city: Sofia
country: Bulgaria
facility: MHAT"Sveti Ivan Rilski"
city: Varna
country: Bulgaria
facility: MHAT "Sveta Anna"
city: Bordeaux
country: France
facility: Polyclinique de Bordeaux-Nord
city: Limoges Cedex
country: France
facility: Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren
city: Bad König
country: Germany
facility: KfH Nierenzentrum
city: Berlin
country: Germany
facility: KfH Nierenzentrum
city: Essen
country: Germany
facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Slzrx
country: Germany
facility: Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis
city: Weinheim
country: Germany
facility: Nierenzentrum Weinheim Kreiskrankenhaus Weinheim
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Nefrologie Dr. Carol Davila
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Deva
country: Romania
facility: Spitalul Judetean de Urgenta Deva
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu"
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean Timisoara
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Pamplona
country: Spain
facility: Hospital de Navarra
Study officials:
affiliation: Hexal AG
name: Karsten Roth
role: STUDY_CHAIR
References: