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Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)

Sponsor
Genexine, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02044653
Collaborator
(none)
257
Enrollment
5
Locations
13
Arms
36.2
Actual Duration (Months)
51.4
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of study is

  • 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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The secondary objective of study is to evaluate:

  • 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

Study Design

Study Type:
Interventional
Actual Enrollment :
257 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Phase II Clinical Trial to Explore the Optimal Fixed Starting Dose & Dosing Interval and to Evaluate the Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease and Receiving Hemodialysis (HD) / Peritoneal Dialysis (PD)
Actual Study Start Date :
Apr 15, 2014
Actual Primary Completion Date :
Apr 20, 2017
Actual Study Completion Date :
Apr 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (Part A)

GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 3ug/kg

Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Other Names:
  • GC1113

    		•
    Experimental: Group B (Part A)

    GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg

    Drug: GX-E2
    Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group C (Part A)

    GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg

    Drug: GX-E2
    Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group D (Part A)

    GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 3ug/kg

    Drug: GX-E2
    Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group E (Part A)

    GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 5ug/kg

    Drug: GX-E2
    Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group F (Part A)

    GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 8ug/kg

    Drug: GX-E2
    Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group G (Part B)

    GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg

    Drug: GX-E2
    Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group H (Part B)

    GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg

    Drug: GX-E2
    Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Active Comparator: Group I (Part B)

    MIRCERA : Subcutaneously injection every 2 weeks (Q2W) at dose 0.6ug/kg

    Drug: MIRCERA
    Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg
    Other Names:
  • Methoxy Polyethylene glycol-epoetin beta

    		•
    Experimental: Group J (Part B)

    GX-E2 : Intravenously injection every week (Q1W) at dose 5ug/kg

    Drug: GX-E2
    Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group K (Part B)

    GX-E2 : Intravenously injection every week (Q1W) at dose 8ug/kg

    Drug: GX-E2
    Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Experimental: Group L (Part B)

    GX-E2 : Intravenously injection every 2 weeks (Q2W) at dose 8ug/kg

    Drug: GX-E2
    Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
    Other Names:
  • GC1113

    		•
    Active Comparator: Group M (Part B)

    NESP : Intravenously injection every week (Q1W) at dose 30ug

    Drug: NESP
    Each Group of Hemodialysis (n=30) will be administered NESP 30ug
    Other Names:
  • Aranesp
  • Darbepoetin alfa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. average change of Hemoglobin level [6 weeks (Part A) & 14 weeks (Part B)]

      change from baseline in Hemoglobin level

    Secondary Outcome Measures

    1. change of red blood cell indices [6 weeks (Part A) & 14 weeks (Part B)]

      change from baseline in red blood cell indices

    2. change of reticulocyte indices [6 weeks (Part A) & 14 weeks (Part B)]

      change from baseline in reticulocyte indices

    3. incidence, degree, outcome of adverse event [6 weeks (Part A) & 14 weeks (Part B)]

      Incidence of adverse events

    4. incidence, frequency, amount of blood transfusion [6 weeks (Part A) & 14 weeks (Part B)]

      Incidence of adverse events

    5. immunogenicity: ratio of neutralizing antibody & binding antibody in subjects [6 weeks (Part A) & 14 weeks (Part B)]

      comparison from pre-treatment to post-treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent

    • ≥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:

    • Refractory to erythropoiesis stimulating agent (ESA) treatment

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bucheon St. Mary's Hospital Bucheon Korea, Republic of
    2 Bundang Seoul National University College of Medicine Gumi Korea, Republic of
    3 The Catholic University of Korea Incheon St.Mary's Hospital Incheon Korea, Republic of
    4 Gangnam severance hospital Seoul Korea, Republic of
    5 Seoul St.Mary's Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Genexine, Inc.

    Investigators

    • Principal Investigator: Chul-Woo Yang, MD, 222 Banpo-daero, Seocho-gu, Seoul, Korea
    • Principal Investigator: Seok Joon Shin, MD, 56 Dongsuro, Pupyung-Gu, Incheon, Korea
    • Principal Investigator: Ki Young Na, MD, 82 Gumi-ro, 173 Beon-gil, Bundnag-gu, Seongnam-si, Gyeonggi-do, Korea
    • Principal Investigator: Ho cheol Song, MD, 327 sosaro, onemi-Gu, bucheon, Korea
    • Principal Investigator: Hyeong cheoon Park, MD, 211 Eonju-ro, Gangnam-gu, Seoul, Korea
    • Principal Investigator: Young Sun Kang, MD, 123 Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
    • Principal Investigator: Eun Young Seong, MD, 176 Gudeok-ro, Seo-gu, Busan, Korea
    • Principal Investigator: Yong-Lim Kim, MD, 130 Dongdeok-ro, Jung-gu, Dae-gu, Korea
    • Principal Investigator: Sangho Lee, MD, 892 Dongnam-ro, Gangdong-gu, Seoul, Korea
    • Principal Investigator: Byung Chul Shin, MD, 365 Pilmun-daero, Dong-gu, Gwangju Metropolitan City
    • Principal Investigator: Su-Hyun Kim, MD, 102 Heukseok-ro, Dongjak-gu, Seoul, Korea
    • Principal Investigator: Hyung Wook Kim, MD, 93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, Korea
    • Principal Investigator: Won Kim, MD, 20 Geonjiro Deokjin-gu, Jeonju-si, Jeollabuk-do, Korea
    • Principal Investigator: Young-il Jo, MD, 4-12 Hwayang-dong, Gwangjin-gu, Seoul, Korea
    • Principal Investigator: Sug Kyun Shin, MD, 100 Ilsan-ro, Ilsan-donggu, Goyang-si, Gyeonggi-do, Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genexine, Inc.
    ClinicalTrials.gov Identifier:
    NCT02044653
    Other Study ID Numbers:
    • GX-E2_P2
    First Posted:
    Jan 24, 2014
    Last Update Posted:
    Oct 16, 2017
    Last Verified:
    Oct 1, 2017
    Keywords provided by Genexine, Inc.
    Phase 2
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Darbepoetin alfa

    Study Results

    No Results Posted as of Oct 16, 2017