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A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD) (CKD)

Primary Purpose

Anemia, Chronic Kidney Disease Requiring Chronic Dialysis

Status

Active

Phase

Phase 3

Locations

Vietnam

Study Type

Interventional

Intervention

Stimus (NNG-DEPO)

About this trial

This is an interventional treatment trial for Anemia focused on measuring CKD on dialysis, Nanogen, Anemia, Darbepoetin Alfa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patients signed the informe consent form and adhere to study visit schedule.
Male or female patients aged from 18 to 65 years.
Patients on hemodialysis or peritoneal dialysis for at least 3 months and have Hb baseline <10 g/dL during the screening period.
Have transferrin saturation ≥ 20%, serum ferritin ≥ 200 ng/mL, vitamin B12 and folate within the normal range.
Have expected survival of at least 6 months from time of enrollment (by investigator's assessment).
Women childbearing age must agree to use medically acceptable methods of contraception during the study and for 6 months after the last study treatment.
The patient does not have any serious medical conditions that may affect to study treatment compliance.

Exclusion Criteria:

Uncontrolled hypertension over 2 weeks prior to and within the screening period (BP ≥ 160/90 mmHg).
Patients treated with Darbepoetin alfa or r-HuEPO within 4 weeks prior to enrollment.
Patients with Uncontrolled diabetes mellitus with HbA1C ≥ 10%.
Congestive Heart Failure of grade 3 or 4 as New York Heart Association classification.
History of unstable angina or myocardial infarction within 6 months.
History of Grand mal seizures in last 2 years.
Present with severe hyperparathyroidism (iPTH >1500 pg/mL for Dialysis).
History of major surgery within 12 weeks prior to screening.
Systemic hematologic disorders including sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma and hemolytic anemia.
Systemic infections, active inflammatory diseases and malignancies.
Active liver disease or hepatic with liver enzymes AST and ALT raised > 2-times of laboratory normal values, child B or child C cirrhosis.
Are being treated with androgen therapy within the 8 weeks prior to the screening period.
Pregnant or suspected pregnant women, breast-feeding women.
Patients scheduled for any transplant procedure within 6 months of screening or with a previous history of kidney transplantation.
Patients who are hypersensitive to any of substances of investigational product.
Patients using drugs that can affect the concentration of Hb in the blood (except blood-forming drugs such as iron, folic acid).
Patients with seropositivity to HIV, HBV or anti-HCV.
Patients having acute tuberculosis or any acute bacterial infection within 1 month prior to the screening.
Patient has occult blood in stool or any other known source of internal bleeding and confirmed gastrointestinal bleeding by endoscopy.
Patients with blood transfusion due to acute bleeding within 12 weeks prior to screening period.
Patients with a history of immunosuppressive therapy within 1 month.
The patient is suffering from advanced cancer.
Patients having participated in any other clinical trial within 1 month prior to the screening period.
The patient had any medical condition that the investigator assessed as affecting the study.

Sites / Locations

NANOGEN Pharmaceutical Biotechnology JSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stimus

Aranesp

Arm Description

NNG-DEPO (Darbepoetin alfa 10 mcg/0.4 mL, 20 mcg/0.5 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL) is available as a prefilled syringe in a sterile, colorless, glass tube. Storage: 2-8ºC, not frozen. The process of transporting and storing the drug must ensure the temperature in the range of 2-8ºC. NNG-DEPO/Aranesp is administered subcutaneously (or intravenously) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit. Study drug will be prepared according to standard procedure (SOP). Dosage adjustment guideline: Patients will have hemoglobin levels monitored every 2 weeks. The investigators will evaluate and adjust the dose of Darbepoetin alfa to maintain the Hb levels within the target range (10 - 12 g/dL)

Aranesp® (Darbepoetin alfa 10 mcg/ 0.4 mL, 20 mcg/ 0.5 mL, 40 mcg/ 0.4 mL, 60 mcg/ 0.3 mL) is manufactured by Amgen, as a pre-filled syringe in a sterile, glass tube, colourless. Storage: 2-8ºC, not frozen. The process of transporting and storing the drug must ensure the temperature in the range of 2-8ºC. NNG-DEPO/Aranesp is administered subcutaneously (or intravenously) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit. Study drug will be prepared according to standard procedure (SOP). Dosage adjustment guideline: Patients will have hemoglobin levels monitored every 2 weeks. The investigators will evaluate and adjust the dose of Darbepoetin alfa to maintain the Hb levels within the target range (10 - 12 g/dL)

Outcomes

Primary Outcome Measures

The mean change Hemoglobin level from baseline to Week 24

Secondary Outcome Measures

Proportion of patients achieving 1 g/dL rise in Hb from baseline during 24 weeks after treatment

Proportion of patients achieving Hb within the target range (10 - 12 g/dL) at week 24.

Proportion of patients need for blood transfusion during 24 weeks after treatment.

4. The mean dose of NNG-DEPO/Aranesp administered for achievement of Hb in the target Hb levels (10 - 12 g/dL) during 24 weeks.

Time to initial achievement of Hb ≥ 11 g/dL.

Proportion of the adverse events (AE) including physical examinations, vital signs, and clinical laboratory investigations.

Proportion of patients positive with anti-Darbepoetin alfa antibody after treatment.

Full Information

NCT ID

NCT05585645

First Posted

October 14, 2022

Last Updated

January 4, 2023

Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

Collaborators

Vietstar Biomedical Research, MEDPHASE CLINICAL RESEARCH CONSULTANT COMPANY LIMITED, CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED, MedProve Inc

1. Study Identification

Unique Protocol Identification Number

NCT05585645

Brief Title

A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD)

Acronym

CKD

Official Title

A Multicenter, Double-blind, Randomized, Parallel Comparative Study of Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 8, 2019 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

Collaborators

Vietstar Biomedical Research, MEDPHASE CLINICAL RESEARCH CONSULTANT COMPANY LIMITED, CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED, MedProve Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a double-blind, two-arm, randomized, multicenter to compare the efficacy and safety of NNG-DEPO and Aranesp in CKD on dialysis patients. Patients aged 18 to 65 years (inclusive), diagnosed with anemia due to CKD in dialysis, who meet all inclusion criteria, requiring treatment with Darbepoetin alfa. The study subjects (patients) will be randomized into a 1:1 ratio to NNG-DEPO and Aranesp treatment arms respectively. Patients will receive either NNG-DEPO or Aranesp 0.75 µg/kg by subcutaneous injection every other week for 24 weeks. During the treatment, dose adjustments will be made as necessary to achieve a hemoglobin response, defined as maintaining Hb in the target range of 10 - 12 g/dL.

Detailed Description

The phase of the study: phase 3 Study sites: Nguyen Tri Phuong Hospital Thu Duc City Hospital An Sinh Hospital Thong Nhat General Hospital Dong Nai Sample size: 214 patients TARGET POPULATION: Patients with chronic kidney disease undergoing dialysis (aged 18 to 65 years) STUDY GROUPS: Darbepoetin alfa (Nanogen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks. Aranesp® (Amgen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks. Blood sample will be taken for Complete Blood Count (CBC) test at each visit (Week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24) to monitor haemoglobin response. Study Procedures: This study was designed for 26 weeks (2 weeks for screening and 24 weeks for treatment) and there are total of 14 visits: Visit 1 is the screening visit. Visit 2: Randomization, initiate study treatment, assess the Hb baseline. Visit 3 - 7 is to monitor, evaluate the efficacy, safety. Visit 8 is to interim assess the efficacy, safety for each patient to make the decision continous/discontinous the study treatment. Vist 9 -13 is to monitor, evaluate the efficacy, safety. Visit 14 is termination visit. SAFETY AND TOLERABILITY ASSESSMENT: Safety and tolerability assessments will be performed at each visit. Following variables will be considered to define the safety and tolerability of investigational drugs: Clinical adverse events (AEs): frequency of AEs, overall and by intensity. Severe clinical adverse events (SAEs): frequency of AEs, overall and by intensity. Symptoms directed physical examination including body weight, and vital signs during treatment period: mean change from baseline and the frequency of clinically relevant changes from baseline. Laboratory tests: frequency of clinically relevant changes from baseline. The frequency of any concomitant medication administered to treat any adverse events. Presence of darbepoetin alfa anti-bodies (immunogenicity).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

CKD on dialysis, Nanogen, Anemia, Darbepoetin Alfa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stimus

Arm Type

Experimental

Arm Description

Arm Title

Aranesp

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Stimus (NNG-DEPO)

Intervention Description

Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe

Primary Outcome Measure Information:

Title

The mean change Hemoglobin level from baseline to Week 24

Time Frame

Week 0 (Assessed predose)- Week 24

Secondary Outcome Measure Information:

Title

Proportion of patients achieving 1 g/dL rise in Hb from baseline during 24 weeks after treatment

Time Frame

Week 0 (Assessed predose)- Week 24

Title

Proportion of patients achieving Hb within the target range (10 - 12 g/dL) at week 24.

Time Frame

Week 24

Title

Proportion of patients need for blood transfusion during 24 weeks after treatment.

Time Frame

Week 0 (Assessed predose)- Week 24

Title

4. The mean dose of NNG-DEPO/Aranesp administered for achievement of Hb in the target Hb levels (10 - 12 g/dL) during 24 weeks.

Time Frame

Week 0 (Assessed predose)- Week 24

Title

Time to initial achievement of Hb ≥ 11 g/dL.

Time Frame

Week 0 (Assessed predose)- Week 24

Title

Proportion of the adverse events (AE) including physical examinations, vital signs, and clinical laboratory investigations.

Time Frame

Week 0 (Assessed predose)- Week 24

Title

Proportion of patients positive with anti-Darbepoetin alfa antibody after treatment.

Time Frame

Week 0 (Assessed predose)- Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patients signed the informe consent form and adhere to study visit schedule. Male or female patients aged from 18 to 65 years. Patients on hemodialysis or peritoneal dialysis for at least 3 months and have Hb baseline <10 g/dL during the screening period. Have transferrin saturation ≥ 20%, serum ferritin ≥ 200 ng/mL, vitamin B12 and folate within the normal range. Have expected survival of at least 6 months from time of enrollment (by investigator's assessment). Women childbearing age must agree to use medically acceptable methods of contraception during the study and for 6 months after the last study treatment. The patient does not have any serious medical conditions that may affect to study treatment compliance. Exclusion Criteria: Uncontrolled hypertension over 2 weeks prior to and within the screening period (BP ≥ 160/90 mmHg). Patients treated with Darbepoetin alfa or r-HuEPO within 4 weeks prior to enrollment. Patients with Uncontrolled diabetes mellitus with HbA1C ≥ 10%. Congestive Heart Failure of grade 3 or 4 as New York Heart Association classification. History of unstable angina or myocardial infarction within 6 months. History of Grand mal seizures in last 2 years. Present with severe hyperparathyroidism (iPTH >1500 pg/mL for Dialysis). History of major surgery within 12 weeks prior to screening. Systemic hematologic disorders including sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma and hemolytic anemia. Systemic infections, active inflammatory diseases and malignancies. Active liver disease or hepatic with liver enzymes AST and ALT raised > 2-times of laboratory normal values, child B or child C cirrhosis. Are being treated with androgen therapy within the 8 weeks prior to the screening period. Pregnant or suspected pregnant women, breast-feeding women. Patients scheduled for any transplant procedure within 6 months of screening or with a previous history of kidney transplantation. Patients who are hypersensitive to any of substances of investigational product. Patients using drugs that can affect the concentration of Hb in the blood (except blood-forming drugs such as iron, folic acid). Patients with seropositivity to HIV, HBV or anti-HCV. Patients having acute tuberculosis or any acute bacterial infection within 1 month prior to the screening. Patient has occult blood in stool or any other known source of internal bleeding and confirmed gastrointestinal bleeding by endoscopy. Patients with blood transfusion due to acute bleeding within 12 weeks prior to screening period. Patients with a history of immunosuppressive therapy within 1 month. The patient is suffering from advanced cancer. Patients having participated in any other clinical trial within 1 month prior to the screening period. The patient had any medical condition that the investigator assessed as affecting the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bui V Pham, MD. PhD

Organizational Affiliation

Nguyen Tri Phuong Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

NANOGEN Pharmaceutical Biotechnology JSC

City

Ho Chi Minh City

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Not yet infomation

Learn more about this trial

A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD)

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