- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155125
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Gosford, New South Wales, Australia, 2250
- Renal Research Gosford
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Tasmania
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Launceston, Tasmania, Australia, 7250
- Launceston General Hospital
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Jakarta Pusat, Indonesia
- Rspad Gatot Soebroto
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Jakarta Pusat, Indonesia
- Rumah Sakit Islam Jakarta Cempaka Putih
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Jakarta Pusat, Indonesia
- Rumah Sakit Islam Jakarta Pondok Kopi
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Jakarta Pusat, Indonesia
- Rumah Sakit Pgi Cikini
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Jakarta Pusat, Indonesia
- Rumah Sakit Umum Pusat Fatmawati
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Jakarta Pusat, Indonesia
- Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo
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Daejeon, Korea, Republic of
- Chungnam National University Hospital
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Gyeonggi-do, Korea, Republic of
- Seoul National University Bundang Hospital
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Gyeonggi-do, Korea, Republic of
- Korea University Ansan Hospital
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Incheon, Korea, Republic of
- The Catholic University of Korea Incheon St. Mary's Hospital
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Sejong, Korea, Republic of
- Chungnam National University Sejong Hospital
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Seoul, Korea, Republic of
- The Catholic University of Korea Seoul St. Mary'S Hospital
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Seoul, Korea, Republic of
- Kyung Hee University Hospital at Gangdong
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Seoul, Korea, Republic of
- The Catholic University of Korea, Yeouido St. Mary's Hospital
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Seoul, Korea, Republic of
- The Catholic University of Korea Eunpyeong St. Mary's Hospital
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Ipoh, Malaysia, 30450
- Hospital Raja Permaisuri Bainun
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Kajang, Malaysia, 43000
- Hospital Kajang
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Kota Bharu, Malaysia, 15200
- Hospital Raja Perempuan Zainab II
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Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
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Kuantan, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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Serdang, Malaysia, 43000
- Hospital Serdang
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Sibu, Malaysia, 96000
- Hospital Sibu
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Perak
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Seri Manjung, Perak, Malaysia, 32040
- Seri Manjung Hospital
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Selangor
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Kuala Lumpur, Selangor, Malaysia, 59100
- University of Malaya Medical Centre
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Bacolod City, Philippines, 6100
- M3 Dialysis Center
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Baguio, Philippines, 2600
- Baguio General Hospital Medical Center
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Cebu City, Philippines, 6000
- Norzel Medical and Diagnostic Clinic
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Dasmariñas, Philippines, 4114
- De La Salle Medical and Health Sciences Institute
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Davao City, Philippines, 8000
- Davao Doctors Hospital
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Iloilo City, Philippines, 5000
- West Visayas State University Hospital
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Quezon, Philippines, 1101
- National Kidney and Transplant Institute
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Changhua, Taiwan, 100
- Changhua Christian Hospital
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Hualien City, Taiwan, 970
- Hualien Tzu Chi Hospital
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Kaohsiung, Taiwan, 80756
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung, Taiwan, 813
- Kaohsiung Veterans General Hospital
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Kaohsiung, Taiwan, 83301
- Kaohsiung Chang Gung Hospital
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Keelung, Taiwan, 204
- Keelung Chang Gung Memorial Hospital
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Taichung, Taiwan, 433
- Kuang Tien General Hospital
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Taichung, Taiwan, 40705
- Taiching Veterans General Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Tainan, Taiwan, 433
- Chi Mei Medical Center
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Taipei, Taiwan, 114
- Tri-Service General Hospital
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Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
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Taipei, Taiwan, 235
- Taipei Medical University - Shuang Ho Hospital
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Taoyuan, Taiwan, 833
- Linkou Chang Gung Memorial Hospital
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Bangkok, Thailand, 10330
- Vajira Hospital
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Chiang Mai, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Pathum Thani, Thailand, 12120
- Thammasat University Hospital
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Songkhla, Thailand, 90110
- Songklanagarind Hospital
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Ubon Ratchathani, Thailand, 34000
- Sunpasitthiprasong Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age should be greater than or equal to the minimum age of consent in the applicable country
- Stage 3 or 4 CKD (eGFR ≥ 15 and < 60 mL/min/1.73 m2)
- ESA-naive (no prior ESA use) subjects whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL, or ESA prior users whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL and who have stopped using ESA at least 12 weeks till the screening
- Ferritin ≥ 100 ng/mL and transferrin saturation (TSAT) ≥ 20%
- Subject must be willing to complete all study-related activities and follow-up visits
- Evidence of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion Criteria:
- Need for dialysis therapy expected in the next 12 months or rapid progression of CKD (e.g., eGFR decrease of >20% within 12 weeks)
- Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to screening, or blood transfusion is anticipated during the study period
- Have a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥ 1 g/dL, within the last 8 weeks prior to screening
- Have an unstable Hb for any reason, in the investigator's opinion
- Have non-renal anaemia (any anaemia where the investigator considers the anaemia is predominantly due to a non-renal cause. Non-renal causes include, but are not limited to vitamin B12 or folic acid deficiency, homozygous sickle-cell disease, thalassemia of all types, other non-renal cause of anaemia such as myelodysplasia or haematological malignancies)
- Platelet count of ≤ 50 x109/L
- Vitamin B12 deficiency defined as total serum levels of < 181 pmol/L (246 pg/ml) 10
- Folic acid deficiency defined as total serum levels < 7.63 nmol/L (3.37 ng/mL) 10
- Pure red cell aplasia, or a history of pure red cell aplasia
- Poorly controlled hypertension defined as a sitting SBP ≥170 mmHg and/or DBP ≥100 mm Hg
- Chronic congestive heart failure (New York Heart Association class IV) or are otherwise at high risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before screening or during screening
- Active or not active malignancy (except non-melanoma skin cancer) within five years before screening
- Planned live kidney transplantation scheduled within 52 weeks after the screening visit
- Uncontrolled hyperparathyroidism, in the investigator's opinion
- Uncontrolled hypothyroidism determined by the investigator that they cannot participate in the study
- Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus), or a C-reactive protein level > 15 mg/L. (Routinely screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection is not required in this protocol. By history or current clinical evidence, patients with active acute HBV or HCV infection should be excluded. Chronic HBV/HCV infection with LFTs > 3 times of normal are excluded. Known HIV positive patients are excluded)
- Immunosuppressive therapy (other than corticosteroids for a chronic condition, or tacrolimus/cyclosporine) within 12 weeks prior to baseline
- Life expectancy of less than 52 weeks
- Planned surgery during the study period (excluding minor skin excisions)
- Have received investigational drug(s) other than those of this study within 4 weeks prior to screening, or will receive investigational drug(s) other than those of this study during the study period
- History or clinical evidence of cardiovascular, haematologic or hepatic (ALT, AST, bilirubin values above three times the upper limit of normal [ULN] at screening) or any physical conditions that, in the opinion of the investigator, would compromise participation in the study
- With a cognitive or psychiatric condition rendering the subject unable to be cooperative with and complete study requirements
- Hypersensitivity to any one of the investigational drugs
- Subjects are, in the judgement of the investigator, otherwise inappropriate for entry into the study
- Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are KGBio or CRO employees directly involved in the conduct of the trial
- Participation in other studies involving same investigational drug(s) (Phases 1-4) of this study within 12 weeks before screening
- Females of childbearing potential or males who are unable/unwilling to take adequate contraceptive precautions defined by the protocol for the duration of the study and for at least 28 days after last dose of investigational product. Females have a positive pregnancy test result within 24 hours prior to study entry, is otherwise known to be pregnant, plans to become pregnant in the next 12 months or is currently breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: efepoetin alfa
Route of administration: Subcutaneous Injection. The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period. |
The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.
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Placebo Comparator: Mircera
Route of administration: Subcutaneous Injection. The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL. |
The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range.
During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level.
During the extension period, Hb levels should be maintained between 10 and 12 g/dL.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period
Time Frame: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.
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Measurement is done by an increase in Hb more than or equal to 1 g/dL compared with baseline and a Hb concentration within range of 10 - 12 g/dL inclusive without transfusion during evaluation period
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Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Characterise safety and tolerability of subcutaneous efepoetin alfa is being measured by based on the frequency of adverse events and on the number of out of range laboratory values.
Time Frame: Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration.
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Safety endpoints parameters including Serious Adverse Events (SAE) specified below
It is a composite outcome. Any abnormal test findings during the study will be helpful in reviewing the outcome. |
Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GXE4KGBio-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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