4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney… (NCT01587924) | Clinical Trial Compass
CompletedPhase 2
4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
United States80 participantsStarted 2012-05-23
Plain-language summary
This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia associated with chronic kidney disease. The study consists of a screening phase of 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease after switching from a stable maintenance dose of recombinant human erythropoetin (rhEPO).
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Age and weight: \>/=18 years of age and \>/=45 kg (weight post-dialysis).
✓. On three times weekly hemodialysis for at least 8 weeks, irrespective of eGFR values and stage of chronic kidney disease (CKD).
✓. A single-pool Kt/Vurea of \>/=1.2 based on a historical value obtained within the prior month in order to ensure the adequacy of dialysis. If Kt/Vurea is not available, then an average of the last 2 values of urea reduction ratio (URR) of at least 65%.
✓. rhEPO use: Using the same rhEPO (epoetins or darbepoetin) with total weekly doses that varied by no more than 50% during the prior 4 weeks (i.e., maximum vs. minimum total weekly doses \</=50%).
✕. Dialysis modality: On peritoneal dialysis OR planned change in dialysis modality within the study time period.
✕. rhEPO Hyporesponders: As defined by an epoetin dose of \>/=360 IU/kg/week IV or darbepoetin dose of \>/=1.8 µg/kg/week IV within the prior 8 weeks.
✕. Renal transplant: Renal transplant anticipated or scheduled within the study time period or subjects with a functioning renal transplant.
✕. Mircera or Peginesatide: Current or prior use (within the prior 8 weeks) of Mircera (methoxy polyethylene glycol epoetin beta) OR peginesatide.
✕. Total CPK: \>5x the upper limit of the reference range.
✕. HIV: Positive HIV antibody.
✕. History of myocardial infarction or acute coronary syndrome within the prior 6 months.
✕. History of stroke or transient ischemic attacks (TIAs) within the prior 6 months.