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

NCT02044653 | Completed Phase 2 DMC

• 1 other identifier: GX-E2_P2
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 5

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

Conditions

Anemia; Chronic Kidney Disease

Keywords

Phase 2

Outcome Measures

Primary Outcomes (1)

• average change of Hemoglobin level

  change from baseline in Hemoglobin level

  6 weeks (Part A) & 14 weeks (Part B)

Secondary Outcomes (5)

• change of red blood cell indices

  6 weeks (Part A) & 14 weeks (Part B)

• change of reticulocyte indices

  6 weeks (Part A) & 14 weeks (Part B)

• incidence, degree, outcome of adverse event

  6 weeks (Part A) & 14 weeks (Part B)

• incidence, frequency, amount of blood transfusion

  6 weeks (Part A) & 14 weeks (Part B)

• immunogenicity: ratio of neutralizing antibody & binding antibody in subjects

  6 weeks (Part A) & 14 weeks (Part B)

Study Arms (13)

Group A (Part A)

EXPERIMENTAL

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

Drug: GX-E2

Group B (Part A)

EXPERIMENTAL

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

Drug: GX-E2

Group C (Part A)

EXPERIMENTAL

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

Drug: GX-E2

Group D (Part A)

EXPERIMENTAL

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

Drug: GX-E2

Group E (Part A)

EXPERIMENTAL

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

Drug: GX-E2

Group F (Part A)

EXPERIMENTAL

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

Drug: GX-E2

Group G (Part B)

EXPERIMENTAL

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

Drug: GX-E2

Group H (Part B)

EXPERIMENTAL

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

Drug: GX-E2

Group I (Part B)

ACTIVE COMPARATOR

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

Drug: MIRCERA

Group J (Part B)

EXPERIMENTAL

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

Drug: GX-E2

Group K (Part B)

EXPERIMENTAL

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

Drug: GX-E2

Group L (Part B)

EXPERIMENTAL

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

Drug: GX-E2

Group M (Part B)

ACTIVE COMPARATOR

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

Drug: NESP

Interventions

GX-E2 DRUG

Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg

Also known as: GC1113

Group A (Part A); Group B (Part A); Group C (Part A); Group D (Part A); Group E (Part A); Group F (Part A)

NESP DRUG

Each Group of Hemodialysis (n=30) will be administered NESP 30ug

Also known as: Aranesp, Darbepoetin alfa

Group M (Part B)

MIRCERA DRUG

Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg

Also known as: Methoxy Polyethylene glycol-epoetin beta

Group I (Part B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (5)

Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Location

Bundang Seoul National University College of Medicine

Gumi, South Korea

Location

The Catholic University of Korea Incheon St.Mary's Hospital

Incheon, South Korea

Location

Gangnam severance hospital

Seoul, South Korea

Location

Seoul St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

GC1113; Darbepoetin alfa; continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 24, 2014
• Study Start: April 15, 2014
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

KR (5)