Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)

Anemia Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00869856
• Other study ID #: HX575-304
• Status: Withdrawn
• Phase: Phase 3
• First received: March 25, 2009
• Last updated: June 1, 2015
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: June 2015
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Renal Insufficiency
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• HX575 solution for s.c. administration
Containing different strengths of epoetin alfa (1 to 10 KIU), s.c. injection, 1x per week (qw) or 1x every two weeks (q2w), injection into abdomen or upper thigh

Locations

Country	Name	City	State
Bulgaria	MHAT "Dr. Tota Venkova"	Gabrovo
Bulgaria	MHAT Pazardzhik	Pazardzhik
Bulgaria	MHAT"Sveti Ivan Rilski"	Sofia
Bulgaria	MHAT "Sveta Anna"	Varna
France	Polyclinique de Bordeaux-Nord	Bordeaux
France	Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren	Limoges Cedex
Germany	KfH Nierenzentrum	Bad König
Germany	KfH Nierenzentrum	Berlin
Germany	Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel	Essen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis	Slzrx
Germany	Nierenzentrum Weinheim Kreiskrankenhaus Weinheim	Weinheim
Romania	Spitalul Clinic de Nefrologie Dr. Carol Davila	Bucuresti
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucuresti
Romania	Spitalul Judetean de Urgenta Deva	Deva
Romania	Spitalul Clinic Municipal "Dr. Gavril Curteanu"	Oradea
Romania	Spitalul Clinic Judetean Timisoara	Timisoara
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
Spain	Hospital de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Countries where clinical trial is conducted

Bulgaria,  France,  Germany,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin level		36 weeks	No
Secondary	To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.		36 weeks	Yes