Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01977573




Registration number
NCT01977573
Ethics application status
Date submitted
24/10/2013
Date registered
6/11/2013
Date last updated
12/10/2018

Titles & IDs
Public title
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
Scientific 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.
Secondary ID [1] 0 0
113747
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1278863
Treatment: Drugs - rhEPO

Experimental: GSK1278863 - Subjects 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

Other: Control - 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.


Treatment: Drugs: GSK1278863
Film-coated tablets containing 0.5 mg, 1 mg, 2 mg, 5mg or matching placebo

Treatment: Drugs: rhEPO
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..
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Summary of Hemoglobin (Hgb) Concentration at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Number of Participants Reaching Pre-defined Hgb Stopping Criteria
Timepoint [2] 0 0
Over a period of 24 Weeks
Secondary outcome [3] 0 0
Percent Change From Baseline in Hepcidin Concentration at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)
Timepoint [5] 0 0
Baseline and up to Week 24
Secondary outcome [6] 0 0
Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24
Timepoint [6] 0 0
Weeks 12 to 24
Secondary outcome [7] 0 0
Change From Baseline in Ferritin Concentration at Week 24
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Change From Baseline in Transferrin Concentration at Week 24
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Percent Change From Baseline in Transferrin Saturation at Week 24
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Change From Baseline in Total Iron at Week 24
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24
Timepoint [12] 0 0
Baseline and Week 24
Secondary outcome [13] 0 0
Change From Baseline in Hematocrit at Week 24
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
Change From Baseline in Red Blood Cell Count at Week 24
Timepoint [14] 0 0
Baseline and Week 24
Secondary outcome [15] 0 0
Change From Baseline in Reticulocyte Cell Count at Week 24
Timepoint [15] 0 0
Baseline and Week 24
Secondary outcome [16] 0 0
Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Mean Number of Dose Adjustments up to 24 Weeks
Timepoint [17] 0 0
From Week 4 up to 24 Weeks
Secondary outcome [18] 0 0
Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency
Timepoint [18] 0 0
From week 4 up to 24 weeks
Secondary outcome [19] 0 0
Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20
Timepoint [19] 0 0
From Week 4 up to Week 20
Secondary outcome [20] 0 0
Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks
Timepoint [20] 0 0
Up to 24 Weeks
Secondary outcome [21] 0 0
Mean Final Dose of GSK1278863 up to 24 Weeks
Timepoint [21] 0 0
Up to 24 Weeks
Secondary outcome [22] 0 0
Number of Hemoglobin (Hgb) Excursions
Timepoint [22] 0 0
Up to 24 Weeks.
Secondary outcome [23] 0 0
Number of Hemoglobin (Hgb) Cycles up to 24 Weeks
Timepoint [23] 0 0
Up to 24 Weeks
Secondary outcome [24] 0 0
Number of Dose Cycles up to 24 Weeks
Timepoint [24] 0 0
Up to 24 weeks
Secondary outcome [25] 0 0
Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks.
Timepoint [25] 0 0
Up to 24 weeks
Secondary outcome [26] 0 0
Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks
Timepoint [26] 0 0
Up to 24 weeks
Secondary outcome [27] 0 0
Number of Participants With at Least One Dose Cycle up to 24 Weeks
Timepoint [27] 0 0
Up to 24 weeks
Secondary outcome [28] 0 0
Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline
Timepoint [28] 0 0
From Day 1 up to Week 28
Secondary outcome [29] 0 0
Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit
Timepoint [29] 0 0
From Week 4 up to Week 24

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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).
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2015
Sample size
Target
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Czechia
State/province [16] 0 0
Cheb
Country [17] 0 0
Czechia
State/province [17] 0 0
Liberec
Country [18] 0 0
Czechia
State/province [18] 0 0
Louny
Country [19] 0 0
Czechia
State/province [19] 0 0
Marianske Lazne
Country [20] 0 0
Czechia
State/province [20] 0 0
Most
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 10
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 2
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 4
Country [24] 0 0
Czechia
State/province [24] 0 0
Sokolov
Country [25] 0 0
Denmark
State/province [25] 0 0
Odense C
Country [26] 0 0
Denmark
State/province [26] 0 0
Roskilde
Country [27] 0 0
France
State/province [27] 0 0
Amiens cedex 1
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux
Country [29] 0 0
France
State/province [29] 0 0
Caen Cedex 9
Country [30] 0 0
France
State/province [30] 0 0
Créteil Cedex
Country [31] 0 0
France
State/province [31] 0 0
Lyon Cedex 03
Country [32] 0 0
France
State/province [32] 0 0
Paris Cedex 15
Country [33] 0 0
France
State/province [33] 0 0
Sainte Foy-Lès-Lyon
Country [34] 0 0
Germany
State/province [34] 0 0
Baden-Wuerttemberg
Country [35] 0 0
Germany
State/province [35] 0 0
Bayern
Country [36] 0 0
Germany
State/province [36] 0 0
Mecklenburg-Vorpommern
Country [37] 0 0
Germany
State/province [37] 0 0
Nordrhein-Westfalen
Country [38] 0 0
Germany
State/province [38] 0 0
Sachsen
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Germany
State/province [40] 0 0
Hamburg
Country [41] 0 0
Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Hungary
State/province [42] 0 0
Székesfehérvár
Country [43] 0 0
Japan
State/province [43] 0 0
Aichi
Country [44] 0 0
Japan
State/province [44] 0 0
Gifu
Country [45] 0 0
Japan
State/province [45] 0 0
Gunma
Country [46] 0 0
Japan
State/province [46] 0 0
Ibaraki
Country [47] 0 0
Japan
State/province [47] 0 0
Kanagawa
Country [48] 0 0
Japan
State/province [48] 0 0
Kyoto
Country [49] 0 0
Japan
State/province [49] 0 0
Nagano
Country [50] 0 0
Japan
State/province [50] 0 0
Osaka
Country [51] 0 0
Japan
State/province [51] 0 0
Shiga
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Anyang-Si Gyeonggi-do
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Daegu
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Daejeon
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Gwangju
Country [56] 0 0
Poland
State/province [56] 0 0
Krakow
Country [57] 0 0
Poland
State/province [57] 0 0
Lublin
Country [58] 0 0
Poland
State/province [58] 0 0
Tarnow
Country [59] 0 0
Poland
State/province [59] 0 0
Warszawa
Country [60] 0 0
Poland
State/province [60] 0 0
Zabrze
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Izhevsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Kaluga
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Khantymansiysk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Krasnodar
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Krasnoyarsk
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
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Russian Federation
State/province [67] 0 0
St-Petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Ulyanovsk
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Yaroslavl
Country [70] 0 0
Spain
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Alcala de Henares
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Granada
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Spain
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Madrid
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Spain
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San Sebastian de los Reyes
Country [77] 0 0
Spain
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Santander
Country [78] 0 0
Spain
State/province [78] 0 0
Santiago de Compostela
Country [79] 0 0
Sweden
State/province [79] 0 0
Göteborg
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Sweden
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Karlstad
Country [81] 0 0
Sweden
State/province [81] 0 0
Stockholm
Country [82] 0 0
Sweden
State/province [82] 0 0
Uppsala
Country [83] 0 0
Sweden
State/province [83] 0 0
Örebro
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Chelmsford
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Dorchester
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Dundee
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Hull
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Leeds
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Manchester
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01977573