A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

NCT04155125 | Completed Phase 3 DMC

• 1 other identifier: GXE4KGBio-001
• Study Type: interventional
• Target: 391
• Locations: 7 countries
• Sites: 55

Brief Summary

This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.

Conditions

Anaemia Associated With Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period

  Measurement is done by an increase in Hb more than or equal to 1 g/dL compared with baseline and a Hb concentration within range of 10 - 12 g/dL inclusive without transfusion during evaluation period

  Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.

Secondary Outcomes (1)

• Characterise safety and tolerability of subcutaneous efepoetin alfa is being measured by based on the frequency of adverse events and on the number of out of range laboratory values.

  Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration.

Study Arms (2)

efepoetin alfa

EXPERIMENTAL

Route of administration: Subcutaneous Injection. The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.

Drug: efepoetin alfa

Mircera

PLACEBO COMPARATOR

Route of administration: Subcutaneous Injection. The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.

Drug: Mircera

Interventions

efepoetin alfa DRUG

The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.

efepoetin alfa

Mircera DRUG

The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.

Mircera

Eligibility Criteria

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

You may qualify if:

• Age should be greater than or equal to the minimum age of consent in the applicable country
• Stage 3 or 4 CKD (eGFR ≥ 15 and \< 60 mL/min/1.73 m2)
• ESA-naive (no prior ESA use) subjects whose Hb at baseline is ≥ 8 g/dL and \< 10 g/dL, or ESA prior users whose Hb at baseline is ≥ 8 g/dL and \< 10 g/dL and who have stopped using ESA at least 12 weeks till the screening
• Ferritin ≥ 100 ng/mL and transferrin saturation (TSAT) ≥ 20%
• Subject must be willing to complete all study-related activities and follow-up visits
• Evidence of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

You may not qualify if:

• Need for dialysis therapy expected in the next 12 months or rapid progression of CKD (e.g., eGFR decrease of \>20% within 12 weeks)
• Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to screening, or blood transfusion is anticipated during the study period
• Have a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥ 1 g/dL, within the last 8 weeks prior to screening
• Have an unstable Hb for any reason, in the investigator's opinion
• Have non-renal anaemia (any anaemia where the investigator considers the anaemia is predominantly due to a non-renal cause. Non-renal causes include, but are not limited to vitamin B12 or folic acid deficiency, homozygous sickle-cell disease, thalassemia of all types, other non-renal cause of anaemia such as myelodysplasia or haematological malignancies)
• Platelet count of ≤ 50 x109/L
• Vitamin B12 deficiency defined as total serum levels of \< 181 pmol/L (246 pg/ml) 10
• Folic acid deficiency defined as total serum levels \< 7.63 nmol/L (3.37 ng/mL) 10
• Pure red cell aplasia, or a history of pure red cell aplasia
• Poorly controlled hypertension defined as a sitting SBP ≥170 mmHg and/or DBP ≥100 mm Hg
• Chronic congestive heart failure (New York Heart Association class IV) or are otherwise at high risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before screening or during screening
• Active or not active malignancy (except non-melanoma skin cancer) within five years before screening
• Planned live kidney transplantation scheduled within 52 weeks after the screening visit
• Uncontrolled hyperparathyroidism, in the investigator's opinion
• Uncontrolled hypothyroidism determined by the investigator that they cannot participate in the study

Sponsors & Collaborators

• PT Kalbe Genexine Biologics: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (55)

Renal Research Gosford

Gosford, New South Wales, 2250, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Rspad Gatot Soebroto

Jakarta Pusat, Indonesia

Location

Rumah Sakit Islam Jakarta Cempaka Putih

Jakarta Pusat, Indonesia

Location

Rumah Sakit Islam Jakarta Pondok Kopi

Jakarta Pusat, Indonesia

Location

Rumah Sakit Pgi Cikini

Jakarta Pusat, Indonesia

Location

Rumah Sakit Umum Pusat Fatmawati

Jakarta Pusat, Indonesia

Location

Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo

Jakarta Pusat, Indonesia

Location

Seri Manjung Hospital

Seri Manjung, Perak, 32040, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, Selangor, 59100, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, 30450, Malaysia

Location

Hospital Kajang

Kajang, 43000, Malaysia

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, 15200, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

Hospital Serdang

Serdang, 43000, Malaysia

Location

Hospital Sibu

Sibu, 96000, Malaysia

Location

M3 Dialysis Center

Bacolod City, 6100, Philippines

Location

Baguio General Hospital Medical Center

Baguio City, 2600, Philippines

Location

Norzel Medical and Diagnostic Clinic

Cebu City, 6000, Philippines

Location

De La Salle Medical and Health Sciences Institute

Dasmariñas, 4114, Philippines

Location

Davao Doctors Hospital

Davao City, 8000, Philippines

Location

West Visayas State University Hospital

Iloilo City, 5000, Philippines

Location

National Kidney and Transplant Institute

Quezon, 1101, Philippines

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

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

Incheon, South Korea

Location

Chungnam National University Sejong Hospital

Sejong, South Korea

Location

Kyung Hee University Hospital At Gangdong

Seoul, South Korea

Location

The Catholic University of Korea Eunpyeong St. Mary'S Hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Yeouido St. Mary'S Hospital

Seoul, South Korea

Location

Changhua Christian Hospital

Changhua, 100, Taiwan

Location

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Kaohsiung Chang Gung Hospital

Kaohsiung City, 83301, Taiwan

Location

Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Taiching Veterans General Hospital

Taichung, 40705, Taiwan

Location

Kuang Tien General Hospital

Taichung, 433, Taiwan

Location

Chi Mei Medical Center

Tainan, 433, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital

Taipei, 235, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 833, Taiwan

Location

Vajira Hospital

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Sunpasitthiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Location

MeSH Terms

Interventions

continuous erythropoietin receptor activator

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 7, 2019
• Study Start: July 2, 2020
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

PH (7); TH (6); KR (9); AU (3); TW (15); ID (6); MY (9)