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

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

Interventions

DRUG

GX-E2

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

DRUG

GX-E2

Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg

DRUG

GX-E2

Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg

DRUG

NESP

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

DRUG

MIRCERA

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

Sponsors & Collaborators

• Genexine, Inc.

  lead INDUSTRY

Principal Investigators

• Chul-Woo Yang, MD · 222 Banpo-daero, Seocho-gu, Seoul, Korea

• Seok Joon Shin, MD · 56 Dongsuro, Pupyung-Gu, Incheon, Korea

• Ki Young Na, MD · 82 Gumi-ro, 173 Beon-gil, Bundnag-gu, Seongnam-si, Gyeonggi-do, Korea

• Ho cheol Song, MD · 327 sosaro, onemi-Gu, bucheon, Korea

• Hyeong cheoon Park, MD · 211 Eonju-ro, Gangnam-gu, Seoul, Korea

• Young Sun Kang, MD · 123 Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea

• Eun Young Seong, MD · 176 Gudeok-ro, Seo-gu, Busan, Korea

• Yong-Lim Kim, MD · 130 Dongdeok-ro, Jung-gu, Dae-gu, Korea

• Sangho Lee, MD · 892 Dongnam-ro, Gangdong-gu, Seoul, Korea

• Byung Chul Shin, MD · 365 Pilmun-daero, Dong-gu, Gwangju Metropolitan City

• Su-Hyun Kim, MD · 102 Heukseok-ro, Dongjak-gu, Seoul, Korea

• Hyung Wook Kim, MD · 93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, Korea

• Won Kim, MD · 20 Geonjiro Deokjin-gu, Jeonju-si, Jeollabuk-do, Korea

• Young-il Jo, MD · 4-12 Hwayang-dong, Gwangjin-gu, Seoul, Korea

• Sug Kyun Shin, MD · 100 Ilsan-ro, Ilsan-donggu, Goyang-si, Gyeonggi-do, Korea

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-15

Primary Completion

2017-04-20

Completion

2017-04-20

Countries

• South Korea

Study Locations