Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
This study has been terminated.
(investigation of adverse events in a related clinical study)
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00869856
First received: March 25, 2009
Last updated: August 20, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Chronic Renal Insufficiency |
Drug: HX575 solution for s.c. administration |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in hemoglobin level [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
HX575, EPO Hexal
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869856
Locations
| Bulgaria | |
| MHAT "Dr. Tota Venkova" | |
| Gabrovo, Bulgaria, 5300 | |
| MHAT Pazardzhik | |
| Pazardzhik, Bulgaria, 4400 | |
| MHAT"Sveti Ivan Rilski" | |
| Sofia, Bulgaria, 1431 | |
| MHAT "Sveta Anna" | |
| Varna, Bulgaria, 9000 | |
| France | |
| Polyclinique de Bordeaux-Nord | |
| Bordeaux, France, 33077 | |
| Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren | |
| Limoges Cedex, France, 87042 | |
| Germany | |
| KfH Nierenzentrum | |
| Bad König, Germany, 64732 | |
| KfH Nierenzentrum | |
| Berlin, Germany, 12045 | |
| Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel | |
| Essen, Germany, 23538 | |
| Universitätsklinikum Schleswig-Holstein | |
| Lübeck, Germany, 68309 | |
| Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis | |
| Slzrx, Germany, 55232 | |
| Nierenzentrum Weinheim Kreiskrankenhaus Weinheim | |
| Weinheim, Germany, 69469 | |
| Romania | |
| Spitalul Universitar de Urgenta Bucuresti | |
| Bucuresti, Romania, 050098 | |
| Spitalul Clinic de Nefrologie Dr. Carol Davila | |
| Bucuresti, Romania, 010731 | |
| Spitalul Judetean de Urgenta Deva | |
| Deva, Romania, 330084 | |
| Spitalul Clinic Municipal "Dr. Gavril Curteanu" | |
| Oradea, Romania, 410169 | |
| Spitalul Clinic Judetean Timisoara | |
| Timisoara, Romania, 300736 | |
| Spain | |
| Hospital Universitario Puerta de Hierro | |
| Majadahonda, Spain, 28222 | |
| Hospital de Navarra | |
| Pamplona, Spain, 31008 | |
Sponsors and Collaborators
Novartis
Investigators
| Study Chair: | Karsten Roth | Hexal AG |
More Information
No publications provided
| Responsible Party: | Hexal AG, Sandoz Biopharmaceuticals Development |
| ClinicalTrials.gov Identifier: | NCT00869856 History of Changes |
| Other Study ID Numbers: | HX575-304 |
| Study First Received: | March 25, 2009 |
| Last Updated: | August 20, 2009 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: National Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Spain: Spanish Agency of Medicines |
Keywords provided by Novartis:
|
Treatment associated with CRI |
Additional relevant MeSH terms:
|
Anemia Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic |
Renal Insufficiency Hematologic Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013