Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)
NCT ID: NCT02044653
Last Updated: 2017-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
257 participants
INTERVENTIONAL
2014-04-15
2017-04-20
Brief Summary
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* Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2
* Part B : To evaluate the proof of concept (POC) of GX-E2
Detailed Description
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* change of red blood cell indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
* change of reticulocyte indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
* safety of GX-E2 when administering intravenously/subcutaneously
* incidence of blood transfusion in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
* Immunogenicity in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A (Part A)
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 3ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Group B (Part A)
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Group C (Part A)
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Group D (Part A)
GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 3ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Group E (Part A)
GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 5ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Group F (Part A)
GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 8ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Group G (Part B)
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Group H (Part B)
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Group I (Part B)
MIRCERA : Subcutaneously injection every 2 weeks (Q2W) at dose 0.6ug/kg
MIRCERA
Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg
Group J (Part B)
GX-E2 : Intravenously injection every week (Q1W) at dose 5ug/kg
GX-E2
Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
Group K (Part B)
GX-E2 : Intravenously injection every week (Q1W) at dose 8ug/kg
GX-E2
Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
Group L (Part B)
GX-E2 : Intravenously injection every 2 weeks (Q2W) at dose 8ug/kg
GX-E2
Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
Group M (Part B)
NESP : Intravenously injection every week (Q1W) at dose 30ug
NESP
Each Group of Hemodialysis (n=30) will be administered NESP 30ug
Interventions
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GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
GX-E2
Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
NESP
Each Group of Hemodialysis (n=30) will be administered NESP 30ug
MIRCERA
Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥18 yr of age
* Chronic Kidney diseases with hemodialysis, peritoneal dialysis with Kt/V ≥ 1.2 (hemodialysis) or Kt/V ≥ 1.7 (peritoneal dialysis) within a year
* Adequate transferrin saturation (≥20%), serum ferritin (≥100ug/L)
* Should have received Vitamine B12 ≥ 3 months before the first dose of study agent
* Should have received Folate ≥3 months before the first dose of study agent
* No erythropoietin (EPO) therapy within 2 months before the planned first dose of GX-E2 and Hb\<10g/dL or No EPO therapy within a month (peritoneal dialysis) or 2 weeks (hemodialysis) before the planned first dose of GX-E2 and Hb\<10g/dL.
Exclusion Criteria
* History of blood transfusion within 3 months
* Donation or loss of blood for more than 400 milliliters (mL) within 8 weeks
* History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar ESA drugs
* Acute or chronic organ seizure disorder (including asthma and chronic obstructive pulmonary disease) which may be clinically deteriorated by the drug administration
* Active infection or history of infection that required intravenous injection of antibiotics in the last two months
* Grand Mal epilepsy
* Major surgery within 3 months other than access surgery
* Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
* Ischemic stroke within 3 years
* Chest x-ray findings determined that they cannot participate in the study for clinically abnormal findings by the baseline chest x-ray findings or previously taken chest x-ray findings
* Uncontrolled hypertension
* Congestive heart failure more severe than NYHA functional class III; unstable Coronary artery disease (CAD); myocardial infraction within 3 months
* Uncontrolled arrhythmia
* High risk of thrombosis and embolism
* Systemic blood diseases (e.g. Pure red cell anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia)
* Absolute neutrophil count below 1,500 per microliter (uL) within screening periods
* Platelet count less than 5e10 per liter (L) within screening periods
* Hyperparathyrodism / hypothyrodism
* Splenomegaly caused by anemia or severe splenomegaly (\>20cm)
* Blood aspartate aminotransferase/alanine aminotransferase (ALT/AST) concentration exceeds three times Upper Normal Limit of Normal (UNL)
* Blood total bilirubin concentration exceeds 1.5 times Upper Normal Limit of Normal (UNL)
* Blood albumin concentration below 3g per deciliter (dl)
* History of drug or alcohol abuse in the 6 months prior to the screening
* History of psychotropic or narcotic analgesic drugs dependence within 6 months prior to the screening
* Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted
* Lack of understanding of the study and cooperation (one with no intention to give efforts to perform each evaluation visit and extend previously planned elective surgery)
* Female subjects with childbearing potential who are pregnant, breastfeeding or intends to become pregnant
* Participation in any drug study within 30 days prior to dosing
* Any other ineligible condition at the direction of the investigator that would be ineligible to participate the study
18 Years
80 Years
ALL
No
Sponsors
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Genexine, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chul-Woo Yang, MD
Role: PRINCIPAL_INVESTIGATOR
222 Banpo-daero, Seocho-gu, Seoul, Korea
Seok Joon Shin, MD
Role: PRINCIPAL_INVESTIGATOR
56 Dongsuro, Pupyung-Gu, Incheon, Korea
Ki Young Na, MD
Role: PRINCIPAL_INVESTIGATOR
82 Gumi-ro, 173 Beon-gil, Bundnag-gu, Seongnam-si, Gyeonggi-do, Korea
Ho cheol Song, MD
Role: PRINCIPAL_INVESTIGATOR
327 sosaro, onemi-Gu, bucheon, Korea
Hyeong cheoon Park, MD
Role: PRINCIPAL_INVESTIGATOR
211 Eonju-ro, Gangnam-gu, Seoul, Korea
Young Sun Kang, MD
Role: PRINCIPAL_INVESTIGATOR
123 Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
Eun Young Seong, MD
Role: PRINCIPAL_INVESTIGATOR
176 Gudeok-ro, Seo-gu, Busan, Korea
Yong-Lim Kim, MD
Role: PRINCIPAL_INVESTIGATOR
130 Dongdeok-ro, Jung-gu, Dae-gu, Korea
Sangho Lee, MD
Role: PRINCIPAL_INVESTIGATOR
892 Dongnam-ro, Gangdong-gu, Seoul, Korea
Byung Chul Shin, MD
Role: PRINCIPAL_INVESTIGATOR
365 Pilmun-daero, Dong-gu, Gwangju Metropolitan City
Su-Hyun Kim, MD
Role: PRINCIPAL_INVESTIGATOR
102 Heukseok-ro, Dongjak-gu, Seoul, Korea
Hyung Wook Kim, MD
Role: PRINCIPAL_INVESTIGATOR
93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, Korea
Won Kim, MD
Role: PRINCIPAL_INVESTIGATOR
20 Geonjiro Deokjin-gu, Jeonju-si, Jeollabuk-do, Korea
Young-il Jo, MD
Role: PRINCIPAL_INVESTIGATOR
4-12 Hwayang-dong, Gwangjin-gu, Seoul, Korea
Sug Kyun Shin, MD
Role: PRINCIPAL_INVESTIGATOR
100 Ilsan-ro, Ilsan-donggu, Goyang-si, Gyeonggi-do, Korea
Locations
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Bucheon St. Mary's Hospital
Bucheon-si, , South Korea
Bundang Seoul National University College of Medicine
Gumi, , South Korea
The Catholic University of Korea Incheon St.Mary's Hospital
Incheon, , South Korea
Gangnam severance hospital
Seoul, , South Korea
Seoul St.Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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GX-E2_P2
Identifier Type: -
Identifier Source: org_study_id