4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
Condition: Anaemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group,
      multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in
      approximately 68 subjects with anemia associated with chronic kidney disease who are not
      taking rhEPO and are not undergoing dialysis. The range of Hgb values for study eligibility
      is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once
      daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion.
    

Detailed description: 
      This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group,
      multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in
      approximately 68 subjects with anemia associated with chronic kidney disease who are not
      taking rhEPO and are not undergoing dialysis. The study consists of a screening phase of up
      to 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values
      for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal
      proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a
      double-blind fashion. Study treatment will be stopped if Hgb values fall outside of the range
      pre-specified in the protocol.

      This study aims to estimate the relationship between dose of GSK1278863 and Hgb response for
      correcting anemia in non-dialysis subjects with CKD who are not taking rhEPO (NDD). In
      addition, the study will characterize the effect of GSK1278863 on various
      pharmacokinetic/pharmacodynamic (PK/PD) markers, and will investigate the safety and
      tolerability of GSK1278863.

      An early interim analysis of the Hgb data is planned after approximately 20 subjects from
      cohort 1 have completed 3 weeks of treatment. Depending upon the interim findings, a second
      cohort of subjects may be added to investigate an additional GSK1278863 dose arm. Recruitment
      to the first cohort will continue during the interim analysis.

      A second interim analysis is planned after approximately 48 subjects from cohort 1 have
      completed 4 weeks treatment. The purpose of this interim is three-fold, to investigate
      whether a second cohort of subjects may be added, to facilitate early development of
      dose-response and PK/PD statistical models, and to generate interim results to facilitate
      design and dosing decisions for the next trial.

      Subject completion is defined as completion of all study phases including the follow-up
      phase.
    

Intervention name(s): GSK1278863; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tablet; Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anemia; Prolyl hydroxylase inhibitor; Hemoglobin; Chronic kidney disease; pharmacokinetics; recombinant human erythropoietin; GSK1278863