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AnaemiaPhase 2NCT01977573

A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)

A Phase 2 study testing GSK1278863 and rhEPO in people with Anaemia, run by GlaxoSmithKline at 123 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Anaemia
What is being tested?
GSK1278863 and rhEPO
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
123 sitesin 15 countries
Study dates
31 Oct 2013to 15 Jun 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: >=18 years of age. (Week -4 verification only)
  • Gender: Female and male subjects. (Week -4 verification only) Females: If of childbearing potential, must agree to use one of the approved contraception methods, from Screening until completion of the Follow-up Visit OR Of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy, or oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the approved contraception methods if they wish to continue their HRT during the study. Otherwise they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
  • Corrected QT interval (QTc): Bazett's Correction of QT Interval (QTcB) <470 milliseconds (msec) or QTcB <480 msec in subjects with bundle branch block. There is no QTc criterion for subjects with a predominantly paced rhythm.
  • CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3/4/5 defined by electronic estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
  • Hgb: Group 1 (rhEPO naïve): Baseline Hgb of 8.0-11.0 g/dL (inclusive) (USA sites only: 8.0-10.0 g/dL, inclusive); Group 2 (rhEPO users): Baseline Hgb of 9.0-11.5 g/dL (inclusive) (USA sites only: 9.0-10.5, inclusive).
  • Stable rhEPO dose for rhEPO users: Group 2 subjects must be using the same rhEPO (epoetins or their biosimilars, or darbepoetin) with total weekly doses that varied by no more than 50% during the 4 weeks prior to Week -4. At Day 1 (randomization), confirm that total weekly doses varied by no more than 50% during the screening period.
  • Oral iron therapy: If on oral iron, then doses must not be changed for the 4 weeks prior to Week -4, during the screening phase, and through the first 4 weeks after Randomization.

Who cannot join

  • Dialysis: On dialysis or planning to initiate dialysis during the study.
  • Renal transplant: Pre-emptive or scheduled renal transplant.
  • High rhEPO dose: An epoetin dose of >=360 IU/kg/week intravenous (IV) or >=250 IU/kg/week subcutaneous (SC) or darbepoetin dose of >=1.8 microgram per kilogram per week (mcg/kg/week) IV or SC within the prior 8 weeks through Day 1 (randomization).
  • Use of methoxy polyethylene glycol epoetin beta within the prior 8 weeks through Day 1 (randomization).
  • IV iron therapy: Use of IV iron for 4 weeks prior to Screening Week -4, during the screening phase, and through the first 4 weeks after Randomization
  • Vitamin B12: Below the lower limit of the reference range (may rescreen in a minimum of 8 weeks).
Show all 29Show fewer
  • Folate: <2.0 nanogram per millilitre (ng/mL) (<4.5 nanomoles per liter [nmol/L]) (may rescreen in a minimum of 4 weeks).
  • Ferritin: <40 ng/mL (<40 mcg/L).
  • Transferrin saturation (TSAT): Below the lower limit of the reference range
  • Myocardial infarction or acute coronary syndrome: Within the 8 weeks prior to Screening through Day 1 (randomization).
  • Stroke or transient ischemic attack: Within the 8 weeks prior to Week -4 Screening through Day 1 (randomization).
  • Heart failure: Class III/IV heart failure as defined by the New York Heart Association (NYHA) functional classification system diagnosed prior to Week -4 Screening through Day 1 (randomization), symptomatic right heart failure diagnosed prior to Week -4 Screening through Day 1 (randomization).
  • Uncontrolled hypertension: Defined as diastolic blood pressure (DBP) >100 mmHg or systolic blood pressure (SBP) >170 mmHg at Week -4 and reconfirmed at Day 1.
  • Thrombotic Disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), except vascular access thrombosis within the 8 weeks prior to Week -4 Screening through Day 1 (randomization).
  • Ophthalmology disease: Meeting any ophthalmologic-related exclusion criteria determined at the Screening ophthalmology exam.
  • Inflammatory disease: Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Week -4 Screening through Day 1 (randomization).
  • Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia and thalassemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia other than renal disease diagnosed prior to Week -4 Screening through Day 1 (randomization).
  • Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests [alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 x upper limit of normal (ULN) or total bilirubin >1.5 x ULN]; or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study.
  • Major surgery: Major surgery (excluding vascular access surgery) within the prior 8 weeks, during the Week -4 Screening phase or planned during the study.
  • Transfusion: Blood transfusion within the prior 8 weeks, during the Week -4 Screening phase or an anticipated need for blood transfusion during the study.
  • Gastrointestinal (GI) Bleeding: Evidence of actively bleeding peptic, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within the 8 weeks prior to Week -4 Screening through Day 1 (randomization).
  • Acute infection: Clinical evidence of acute infection or history of infection requiring IV antibiotic therapy within the 8 weeks prior to Week -4 Screening through Day 1 (randomization).
  • Malignancy: Subjects with a history of malignancy within the prior 5 years, who receiving treatment for cancer, or who have a strong family history of cancer (e.g., familial cancer disorders); with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated prior to Week -4 Screening through Day 1 (randomization).
  • Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (see GSK1278863 IB for list of excipients and rhEPO (refer to local product labelling for details).
  • Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Week -4 Screening until the Follow-up Visit.
  • Prior investigational product exposure: The Subject has participated in a clinical trial and has received an experimental investigational product within the prior 30 days from Week -4 Screening through Day 1 (randomization).
  • Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the Investigator considers would put the subject at unacceptable risk.
  • Patient participation: Unwillingness or inability of the subject to follow the procedures or lifestyle or dietary restrictions outlined in the protocol.
  • Pregnancy or Lactation: Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test OR women who are lactating at Week -4 Screening or during the trial.

Trial locations and contacts

123 sites in 15 countries.

123 sites in 15 countries

United States25 sites

  • GSK Investigational Site

    Azusa, California, 91702

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18017

  • GSK Investigational Site

    Charlotte, North Carolina

  • GSK Investigational Site

    Corsicana, Texas, 75110

  • GSK Investigational Site

    Evergreen Park, Illinois, 60805

  • GSK Investigational Site

    Farmington, Missouri, 63640

  • GSK Investigational Site

    Knoxville, Tennessee, 37923

  • GSK Investigational Site

    La Mesa, California, 91942

  • GSK Investigational Site

    Laguna Hills, California, 92653

  • GSK Investigational Site

    Lauderdale Lakes, Florida, 33313

  • GSK Investigational Site

    Los Angeles, California, 90022

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Macon, Georgia, 31217

  • GSK Investigational Site

    Miami, Florida, 33150

  • GSK Investigational Site

    Pembroke Pines, Florida, 33028

  • GSK Investigational Site

    Peoria, Arizona, 85381

  • GSK Investigational Site

    Salt Lake City, Utah, 84112

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Dimas, California, 91773

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    Shreveport, Louisiana, 71101

  • GSK Investigational Site

    Temple, Texas, 76508

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    West Hills, California, 91307

Other trials in United States

Spain12 sites

  • GSK Investigational Site

    Alcalá de Henares, 28805

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08011

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28224

  • GSK Investigational Site

    San Sebastián de los Reyes, 28702

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela, 15706

Other trials in Spain

Japan10 sites

  • GSK Investigational Site

    Aichi, 455-8530

  • GSK Investigational Site

    Gifu, 500-8717

  • GSK Investigational Site

    Gunma, 370-0001

  • GSK Investigational Site

    Ibaraki, 302-0014

  • GSK Investigational Site

    Ibaraki, 302-0022

  • GSK Investigational Site

    Kanagawa, 210-0852

  • GSK Investigational Site

    Kyoto, 604-8845

  • GSK Investigational Site

    Nagano, 388-8004

  • GSK Investigational Site

    Osaka, 558-8558

  • GSK Investigational Site

    Shiga, 523-0082

Other trials in Japan

Russia10 sites

  • GSK Investigational Site

    Izhevsk, 426063

  • GSK Investigational Site

    Kaluga, 248007

  • GSK Investigational Site

    Khantymansiysk, 628012

  • GSK Investigational Site

    Krasnodar, 350029

  • GSK Investigational Site

    Krasnoyarsk, 660062

  • GSK Investigational Site

    Moscow, 119121

  • GSK Investigational Site

    Moscow, 125101

  • GSK Investigational Site

    Saint Petersburg, 197110

  • GSK Investigational Site

    Ulyanovsk, 432063

  • GSK Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Czechia9 sites

  • GSK Investigational Site

    Cheb, 350 02

  • GSK Investigational Site

    Liberec, 460 63

  • GSK Investigational Site

    Louny, 440 01

  • GSK Investigational Site

    Mariánské Lázně, 353 01

  • GSK Investigational Site

    Most, 434 64

  • GSK Investigational Site

    Prague, 100 34

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Prague, 142 00

  • GSK Investigational Site

    Sokolov, 356 01

Other trials in Czechia

United Kingdom9 sites

  • GSK Investigational Site

    Chelmsford, CM1 7ET

  • GSK Investigational Site

    Dorchester, DT1 2JY

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Hull, HU3 2JZ

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    London, E1 1BB

  • GSK Investigational Site

    London, NW3 2QG

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Oxford, OX3 7LE

Other trials in United Kingdom

Canada8 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 5J1

  • GSK Investigational Site

    Kitchener, Ontario, N2G 1E8

  • GSK Investigational Site

    London, Ontario, N6A 5A5

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

Other trials in Canada

Germany8 sites

  • GSK Investigational Site

    Berlin, 12053

  • GSK Investigational Site

    Demmin, Mecklenburg-Vorpommern, 17109

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40210

  • GSK Investigational Site

    Hamburg, 22297

  • GSK Investigational Site

    Leipzig, Saxony, 04129

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Munich, Bavaria, 81675

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

France7 sites

  • GSK Investigational Site

    Amiens, 80054

  • GSK Investigational Site

    Bordeaux, 33000

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Lyon, 69437

  • GSK Investigational Site

    Paris, 75743

  • GSK Investigational Site

    Sainte-Foy-lès-Lyon, 69110

Other trials in France

Hungary5 sites

  • GSK Investigational Site

    Budapest, 1036

  • GSK Investigational Site

    Budapest, 1097

  • GSK Investigational Site

    Budapest, 1115

  • GSK Investigational Site

    Budapest, 1135

  • GSK Investigational Site

    Székesfehérvár, 8000

Other trials in Hungary

Poland5 sites

  • GSK Investigational Site

    Krakow, 31-501

  • GSK Investigational Site

    Lublin, 20-081

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Warsaw, 02-507

  • GSK Investigational Site

    Zabrze, 41-800

Other trials in Poland

Sweden5 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Karlstad, SE-651 85

  • GSK Investigational Site

    Örebro, SE-701 85

  • GSK Investigational Site

    Stockholm, SE-141 86

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Australia4 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Liverpool, New South Wales, 2170

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

South Korea4 sites

  • GSK Investigational Site

    Anyang-Si Gyeonggi-do, 431-070

  • GSK Investigational Site

    Daegu, 700-721

  • GSK Investigational Site

    Daejeon, 301-721

  • GSK Investigational Site

    Gwangju, 501-757

Other trials in South Korea

Denmark2 sites

  • GSK Investigational Site

    Odense C, 5000

  • GSK Investigational Site

    Roskilde, DK-4000

Other trials in Denmark

About this study

Official title: A 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.

This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

Conditions
Anaemia
Being tested
GSK1278863, rhEPO
Keywords
Prolyl hydroxylase inhibitor, pharmacokinetics, GSK1278863, Anemia, hemoglobin, erythropoiesis stimulating agents, Chronic kidney disease
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1278863Drug

    Film-coated tablets containing 0.5 mg, 1 mg, 2 mg, 5mg or matching placebo

  • rhEPODrug

    Locally sourced rhEPO. All subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, to maintain Hgb levels within the target range. The decision around whether a subject requires rhEPO, selection of the type of rhEPO and rhEPO dose should be based on Investigator clinical judgment, with the historical rhEPO dose (where applicable) and the current Hgb value being considered..

Study groups in NCT01977573
Study groupRoleWhat they receive
GSK1278863ExperimentalSubjects will be administered GSK1278863 QD. Starting dose will be based on data from previous studies with GSK1278863 and dose-response modelling, as well as Baseline Hgb concentration. After 4 Week of fixed dose period, dose may be adjusted to achieve Hgb 9.0 to 10.5 g/dL
Receives: Drug: GSK1278863
ControlOtherAll subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, to maintain Hgb levels within the target range. The decision around whether a subject requires rhEPO, selection of the type of rhEPO and rhEPO dose should be based on Investigator clinical judgment, with the historical rhEPO dose (where applicable) and the current Hgb value being considered.
Receives: Drug: rhEPO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Summary of Hemoglobin (Hgb) Concentration at Week 24

    The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original criteria ("Original") and those following the amended ("Amended") criteria. The primary objective was to characterize the ability of GSK1278863 to achieve mean Hgb response within the target range.

    Measured: Week 24

Secondary outcomes (29)

  1. Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24

    Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.

    Measured: Week 24

  2. Number of Participants Reaching Pre-defined Hgb Stopping Criteria

    The Hgb stopping criteria was a value of <7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure.

    Measured: Over a period of 24 Weeks

  3. Percent Change From Baseline in Hepcidin Concentration at Week 24

    Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value.

    Measured: Baseline and Week 24

  4. Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)

    Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baseline values minus the Baseline value.

    Measured: Baseline to Week 24

  5. Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)

    Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-baseline values minus the Baseline value.

    Measured: Baseline and up to Week 24

  6. Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24

    The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.

    Measured: Weeks 12 to 24

  7. Change From Baseline in Ferritin Concentration at Week 24

    Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value.

    Measured: Baseline and Week 24

  8. Change From Baseline in Transferrin Concentration at Week 24

    Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value.

    Measured: Baseline and Week 24

  9. Percent Change From Baseline in Transferrin Saturation at Week 24

    Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value.

    Measured: Baseline and Week 24

  10. Change From Baseline in Total Iron at Week 24

    Baseline is the last pre-dose total iron value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.

    Measured: Baseline and Week 24

  11. Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24

    TIBC measures the blood's capacity to bind iron with transferrin. Baseline is the last pre-dose TIBC value. Change from Baseline in TIBC was calculated by subtracting the Baseline value from the Week 24 value.

    Measured: Baseline and Week 24

  12. Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24

    Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value.

    Measured: Baseline and Week 24

  13. Change From Baseline in Hematocrit at Week 24

    Baseline is the last pre-dose hematocrit value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.

    Measured: Baseline and Week 24

  14. Change From Baseline in Red Blood Cell Count at Week 24

    Baseline is the last pre-dose red blood cell count. Change from Baseline in red blood cell count was calculated by subtracting the Baseline count from the post-dose count.

    Measured: Baseline and Week 24

  15. Change From Baseline in Reticulocyte Cell Count at Week 24

    Reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline is the last pre-dose red reticulocyte count. Change from Baseline in reticulocyte cell count was calculated by subtracting the Baseline count from the Week 24 count.

    Measured: Baseline and Week 24

  16. Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint

    Blood samples were collected for individual plasma GSK1278863 and metabolite (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, and GSK2531403) concentration measurement on Day 1 (pre-dose), Wk 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose). Participants available in each arm at the specified time points have been presented.

    Measured: Day 1 (pre-dose), Week (Wk) 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose)

  17. Mean Number of Dose Adjustments up to 24 Weeks

    After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system.

    Measured: From Week 4 up to 24 Weeks

  18. Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency

    After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. Frequency is presented as the number of participants with dose adjustment(s) once, twice, thrice, four times, or five times.

    Measured: From week 4 up to 24 weeks

  19. Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20

    After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. The number of participants with an adjustment are presented at the timings at which adjustments were done.

    Measured: From Week 4 up to Week 20

  20. Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks

    The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.

    Measured: Up to 24 Weeks

  21. Mean Final Dose of GSK1278863 up to 24 Weeks

    The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.

    Measured: Up to 24 Weeks

  22. Number of Hemoglobin (Hgb) Excursions

    A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. Hgb cycle is calculated as two consecutive Hgb excursions in different directions.

    Measured: Up to 24 Weeks.

  23. Number of Hemoglobin (Hgb) Cycles up to 24 Weeks

    A Hgb cycle is calculated as two consecutive Hgb excursions in different directions. A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.

    Measured: Up to 24 Weeks

  24. Number of Dose Cycles up to 24 Weeks

    A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease).

    Measured: Up to 24 weeks

  25. Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks.

    A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.

    Measured: Up to 24 weeks

  26. Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks

    A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. A Hgb cycle is two consecutive Hgb excursions in different directions.

    Measured: Up to 24 weeks

  27. Number of Participants With at Least One Dose Cycle up to 24 Weeks

    A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants

    Measured: Up to 24 weeks

  28. Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline

    Participants receiving additional therapies of blood transfusions, intravenous (IV) iron or rhEPO any time Post Baseline were analyzed. RhEPO was not applicable for the control arms since it was a planned therapy in those arms, hence presented as NA. (EudraCT only: A value of 99999 is used where no data is available or NA.)

    Measured: From Day 1 up to Week 28

  29. Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit

    Number of Weeks dose was withheld because hemoglobin exceed the upper limit is presented as the number of participants with withheld dose during the time periods categorized by Weeks.

    Measured: From Week 4 up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study start31 Oct 2013
  3. Primary completion1 May 2015
  4. Study completion15 Jun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01977573
Sponsor's protocol ID
113747
Status last verified
Sep 2018
First submitted
24 Oct 2013
Last updated
12 Oct 2018
Data monitoring committee
Yes

Publications

  • Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

    PubMed 36005278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK1278863 and rhEPO in people with Anaemia, run by GlaxoSmithKline at 123 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Spain, Japan, Russia, Czechia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Hemoglobin (Hgb) Concentration at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01977573, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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