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국문

본 임상시험은 다기관, 다국가, 무작위배정, 이중 눈가림, 활성 대조, 병행 설계의 임상시험이다. 본 임상시험은 각 피험자의 증상에 대한 안전성을 평가하고 각 피험자의 베이스라인 특성을 확립하도록 설계된 최소 12 주의 Titration phase가 포함되며, 타당한 사유에 근거하여 Titration phase를 최대 20주까지 연장할 수 있다. Titration phase를 완료한 후, Evaluation period (Maintenance phase의 마지막 4주)가 포함된 28 주의 이중 눈가림 치료단계인 Maintenance phase를 진행한다. Maintenance phase 참여에 적합한 피험자는 무작위배정 계획에 따라 두 가지 임상시험용의약품 (PDA10 또는 Eprex®) 중에서 하나를 투여받도록 1:1 비율로 각 군에 무작위 배정된다. 모든 피험자를 대상으로 PDA10 또는 Eprex® 를 28주간 투여하며 개인별로 임상시험용의약품은 주 1-3회 IV로 투여된다.
모든 절차 또는 평가를 실시하기 전, 서면 동의를 확보한다. 무작위배정 전, 만성신부전 환자를 대상으로 임상시험 참여에 대한 적합성을 확인하기 위해 스크리닝 단계를 거친다. 12 주간의 Titration phase 기간 동안 모든 피험자가 Eprex®를 투여받은 후, Baseline period 동안 Hb 수치가 목표범위인 10.0 – 12.0 g/dL 이내이며 안정적인 Eprex® IV 용량 (개별적으로 적정된)을 투여받은 피험자는 두 가지 임상시험용의약품 중에서 시험약인 PDA10 또는 대조약인 Eprex®를 투여받도록 각 군에 무작위 배정된다. 단, Eprex® 치료를 적어도 12주 이상 받았던 피험자가 Hb 수치가 목표 범위인 10.0 – 12.0 g/dL 이내에 존재하고 안정된 Eprex® IV 용량을 투여받고 있다면 해당 피험자는 본 임상시험의 참여 기준을 확인한 후 Titration phase를 거치지 않고 4주간의 Baseline period (또는 Observation period)을 가지게 된다. Maintenance phase 기간 동안 유효성 및 안전성은 2주 또는 4주마다 평가된다.
28주 시점에서 임상시험을 완료한 피험자들은 24주 간의 공개 연장 임상시험에 참여하여 PDA10 치료를 계속 받도록 제안받게 되며 이 단계에서 장기적인 안전성 및 내약성을 평가한다. 피험자는 공개 연장 임상시험에 참여하기 전 Week 28 (방문 11)의 평가를 완료해야 한다. 28주 시점의 방문 11은 공개 연장 임상시험의 첫 방문 (entry visit)으로 간주한다.

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This clinical study will be a multi-center, multi-national, randomized, double-blind, active-controlled and parallel group clinical trial. This study will consist of a 12-week of titration phase designed to assess the stability of patients’ disease and to establish each patient’s baseline characteristics. In substantiated cases, a prolongation of the titration phase will be allowed up to 20 weeks. The titration phase will be followed by a 28-week double-blind treatment phase (maintenance phase) including the evaluation period (the last 4 weeks of the maintenance phase). Eligible patients will be randomized to receive one of the two study treatment regimen (PDA10 or Eprex®) in a 1:1 ratio according to the randomization scheme. All subjects are to continue their treatment PDA10 or Eprex®, and to receive study medication 1-3 times weekly intravenously (IV).
Prior to performing any procedures or evaluation, written informed consent will be obtained. Prospective patients will be screened to confirm their eligibility for the study entry prior to randomization. During the 12-week of the titration phase, all subjects will receive Eprex®, then those with hemoglobin within the target range of 10.0 to 12.0 g/dl and a stable IV dose (a dosage titrated and individualized) of Eprex® during baseline period will be randomly assigned to one of two study drugs, either to the test product, PDA10, or to the reference product, Eprex®. However, patients on Eprex® treatment for at least 12 weeks and with hemoglobin within the target range of 10.0 to 12.0 g/dl and a stable IV dose of Eprex® will participate in the process of confirming the entry criteria for this study, and have a four-week of the baseline period (or observation period) without the titration phase. During the maintenance phase, the efficacy and safety will be evaluated every 2 or 4 weeks.
Subjects who complete the study at Week 28 will be offered continuation of PDA10 treatment by entering a 24-week of open-label extension phase, and the long-term safety and tolerability will be evaluated. Subjects must complete the Week 28 (Visit 11) assessments before entering the open-label extension phase. Visit 11 at Week 28 of the study will serve as the entry visit for the open label extension phase.

국문

시험약, 용량 및 투여방법:
- 시험약 및 용량: PDA10 프리필드시린지 주 (pre-filled syringe injection) 2000 IU
- 투여방법: 정맥 내 투여 (IV), 주 1~3회
대조약, 용량 및 투여방법:
- 대조약 및 용량: Eprex® (2000 IU/0.5 mL)
- 투여방법: 정맥 내 투여 (IV), 주 1~3회
Maintenance phase 참여에 적합한 환자는 무작위배정 계획에 따라 1:1의 비율로 2가지 치료요법 (PDA10 또는 Eprex®) 중 하나를 투여 받도록 무작위 배정함. 모든 시험대상자는 PDA10 또는 Eprex®의 치료를 지속하였고, 임상시험용 의약품은 주 1-3회 정맥 내로 투여함.

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Test product and its dosage and mode of administration:
- Test product and its dosage: PDA10 Pre-filled syringe injection 2000 IU
- Mode of administration: by intravenous (IV), 1~3 times/week
Reference product and its dosage and mode of administration:
- Reference product and its dosage: Eprex® (2000 IU/0.5 mL)
Eligible patients are randomized to receive one of the two study treatment regimen (PDA10 or Eprex®) in a 1:1 ratio according to the randomization scheme. All subjects are to continue their treatment of PDA10 or Eprex®, and to receive study medication 1-3 times weekly intravenously (IV).
- Mode of administration: by intravenous (IV), 1~3 times/week

상세내용 영문

The IV dose has to be adjusted individually to maintain hemoglobin between 10 - 12 g/dl. The hemoglobin, hematocrit, and dose will be monitored every two weeks during the maintenance phase. Investigators will decide to change or maintain the dosage of Eprex® or PDA10 every four weeks based on Hb level. The dosage will be determined according to the dose adjustment scheme below, and if hemoglobin level is not increased by more than 1 g/dl in any 2-week period or is not approaching 12 g/dl or below 10 g/dl, the dose will be maintained. The maintenance dose should be individualized, and the recommended total weekly dose should not exceed 300 IU/kg. If the hemoglobin increases by more than 1 g/dl in any 2-week period or the hemoglobin is approaching 12 g/d1, the dose should be reduced by approximately 25%. If the hemoglobin continues to increase or exceed 12 g/dl, the dose should be temporarily withheld until the hemoglobin begins to decrease, at which point therapy should be reinitiated at a dose approximately 25% below the previous dose. If dose reduction is needed, either the amount given per dose or the number of weekly injections will be reduced, or both will be reduced.
If the hemoglobin is below 10 g/dl, the dose may be increased by approximately 25% of the previous dose.
When a change in Eprex® or PDA10 dose is indicated, a one-step change (25% of current dosage).

상세내용 영문

The IV dose has to be adjusted individually to maintain hemoglobin between 10 - 12 g/dl. The hemoglobin, hematocrit, and dose will be monitored every two weeks during the maintenance phase. Investigators will decide to change or maintain the dosage of Eprex® or PDA10 every four weeks based on Hb level. The dosage will be determined according to the dose adjustment scheme below, and if hemoglobin level is not increased by more than 1 g/dl in any 2-week period or is not approaching 12 g/dl or below 10 g/dl, the dose will be maintained. The maintenance dose should be individualized, and the recommended total weekly dose should not exceed 300 IU/kg. If the hemoglobin increases by more than 1 g/dl in any 2-week period or the hemoglobin is approaching 12 g/d1, the dose should be reduced by approximately 25%. If the hemoglobin continues to increase or exceed 12 g/dl, the dose should be temporarily withheld until the hemoglobin begins to decrease, at which point therapy should be reinitiated at a dose approximately 25% below the previous dose. If dose reduction is needed, either the amount given per dose or the number of weekly injections will be reduced, or both will be reduced.
If the hemoglobin is below 10 g/dl, the dose may be increased by approximately 25% of the previous dose.
When a change in Eprex® or PDA10 dose is indicated, a one-step change (25% of current dosage).

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End stage renal failure (ESRD)

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Mean change in hemoglobin level between the baseline period and the evaluation period

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The baseline period is the last four weeks of titration phase or the observation period and the evaluation period is the last four weeks of maintenance phase.

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Mean change in weekly dosage per kg body weight between the baseline period and the evaluation period

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The baseline period is the last four weeks of titration phase or the observation period and the evaluation period is the last four weeks of maintenance phase.

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Mean change in hematocrit levels between the baseline period and the evaluation period

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The baseline period is the last four weeks of titration phase or the observation period and the evaluation period is the last four weeks of maintenance phase.

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Proportion of patients with hemoglobin level out of the target range during the maintenance phase

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Maintenance phase period

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Proportion of patients with hemoglobin level within the target range during the evaluation period

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Evaluation period

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Frequency of patients with changes in the dosage per kg body weight

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Maintenance phase period

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Incidence of blood transfusions

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Maintenance phase period