TerminatedPhase 2

Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia

United States15 participantsStarted 2014-06-01

Plain-language summary

The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb) concentration, or maintain it within the target range, and the safety and efficacy of GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who are chronically hyporesponsive to rhEPO. The data generated will inform dose requirements for any chronic rhEPO hyporesponsive hemodialysis-dependent subjects included in future clinical trials. The study consists of a 4-week rhEPO run-in period, a 16-week GSK1278863 treatment period and a 4-week Follow-up period.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Hemodialysis (HD) frequency: Stable HD regimen of three to four times weekly for a minimum of 12 weeks. Note: The type and frequency of dialysis must be stable during the study. Isolated ultrafiltration sessions for the purposes of fluid removal are permitted. * Dialysis Adequacy: Single-pool dialyzer clearance multiplied by dialyzer time divided by volume of distribution of urea (Kt/Vurea) of \>=1.2 based on a historical value obtained within the prior month. * rhEPO hyporesponsiveness: Historical and current intravenous (IV) rhEPO and Hgb values. Average epoetin alfa dose and Hgb level for three 4-week periods for a total of 12 weeks prior to Week -4, and during the 4 week run-in period, must be within the following ranges: average epoetin alfa dose \>4000 and \<=6000 units per session and Hgb \>=8.0 and \<=9.5 g/dL; average epoetin alfa dose \>6000 and \<=8000 units per session and Hgb \>=8.0 and \<=10.0 g/dL; average epoetin alfa dose \>8000 and \<=10000 units per session and Hgb \>=8.0 and \<=10.5 g/dL; and average epoetin alfa dose \>10000 units per session and Hgb \>=8.0 and \<=11.0 g/dL. * Absolute difference between the Hgb value at Week -4 and Week 0 (Day 1), must be \<1.3 g/dL. Note: Subjects who do not meet the criteria after being rescreened twice, should not be entered into the GSK1278863 treatment period and should be withdrawn from the study. * Age: \>=18 years of age. * Q-T Interval Corrected for Heart Rate (QTc): Bazett's Correction of…

What they're measuring

Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16

Timeframe: Week 16

Trial details

NCT IDNCT02075463

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03-01

Results submitted2016-10-24