| Trial ID: | L1173 |
| Source ID: | NCT02079896
|
| Associated Drug: |
Lexaptepid Pegol (Nox-H94)
|
| Title: |
Lexaptepid Pegol (NOX-H94) in ESA-hyporesponsive Anemia in Dialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia|End Stage Renal Disease
|
| Interventions: |
DRUG: Lexaptepid pegol (NOX-H94)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of adverse events, up to 8 weeks | Secondary: Pharmacokinetics, Peak concentrations, systemic exposure, elimination, Weeks 1, 2, 3, 4, 5, 6, 8|Pharmacodynamics, Change in serum iron concentrations, 0 to 48 hours|Efficacy, Change in hemoglobin, Weeks 1, 2, 3, 4, 5, 6, 8
|
| Sponsor/Collaborators: |
Sponsor: TME Pharma AG
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
33
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05
|
| Completion Date: |
2015-11
|
| Results First Posted: |
|
| Last Update Posted: |
2015-11-24
|
| Locations: |
Dialysis Unit, Düsseldorf, Germany|University Hospital, Halle, Germany|Hospital, Leipzig, Germany|Dialysis Unit, Villingen-Schwenningen, Germany|Hospital, Siena, Italy|Hospital, Swansea, Wales, United Kingdom|Hospital, Leicester, United Kingdom|Hospital, London, United Kingdom|King's College London, London, United Kingdom|Lister Hospital, Stevenage, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02079896
|
