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

October 13, 2017 updated by: Genexine, Inc.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Bucheon St. Mary's Hospital
      • Gumi, Korea, Republic of
        • Bundang Seoul National University College of Medicine
      • Incheon, Korea, Republic of
        • The Catholic University of Korea Incheon St.Mary's Hospital
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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=10) will be administered GX-E2 3ug/kg to 8ug/kg
Other Names:
  • GC1113
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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=10) will be administered GX-E2 3ug/kg to 8ug/kg
Other Names:
  • GC1113
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 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 Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Other Names:
  • GC1113
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Other Names:
  • GC1113
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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 Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
Other Names:
  • GC1113
Drug: GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
Other Names:
  • GC1113
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average change of Hemoglobin level
Time Frame: 6 weeks (Part A) & 14 weeks (Part B)
change from baseline in Hemoglobin level
6 weeks (Part A) & 14 weeks (Part B)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of red blood cell indices
Time Frame: 6 weeks (Part A) & 14 weeks (Part B)
change from baseline in red blood cell indices
6 weeks (Part A) & 14 weeks (Part B)
change of reticulocyte indices
Time Frame: 6 weeks (Part A) & 14 weeks (Part B)
change from baseline in reticulocyte indices
6 weeks (Part A) & 14 weeks (Part B)
incidence, degree, outcome of adverse event
Time Frame: 6 weeks (Part A) & 14 weeks (Part B)
Incidence of adverse events
6 weeks (Part A) & 14 weeks (Part B)
incidence, frequency, amount of blood transfusion
Time Frame: 6 weeks (Part A) & 14 weeks (Part B)
Incidence of adverse events
6 weeks (Part A) & 14 weeks (Part B)
immunogenicity: ratio of neutralizing antibody & binding antibody in subjects
Time Frame: 6 weeks (Part A) & 14 weeks (Part B)
comparison from pre-treatment to post-treatment
6 weeks (Part A) & 14 weeks (Part B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2014

Primary Completion (ACTUAL)

April 20, 2017

Study Completion (ACTUAL)

April 20, 2017

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (ESTIMATE)

January 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX-E2_P2

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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