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ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

Primary Purpose

Anemia in Chronic Kidney Disease Patients Not on Dialysis

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

ASP1517

Placebo

About this trial

This is an interventional treatment trial for Anemia in Chronic Kidney Disease Patients Not on Dialysis focused on measuring Chronic Renal Failure, Renal anemia, ASP1517

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic kidney disease with an estimated glomerular filtration rate (as calculated by the Japanese GFR estimation equation) of =<89 mL/min/1.73 m2, and not required dialysis for 3 months since study completion
The mean of two Hb values at screening test and Hb test (at least one week apart form the screening test) is <10.0 g/dL, with a difference of ≤1.0 g/dL between the two values
Both TSAT>=5% and ferritin >=30 ng/mL at screening test
Serum folate ≥4.0 ng/mL and Vitamin B12 ≥180 pg/mL at screening test

Exclusion Criteria:

Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment
Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, celiac disease, etc).
Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or evidence of active gastroparesis.
Uncontrollable hypertension (more than one third blood pressure values of diastolic BP >100 mmHg within 16 weeks prior to screening test including)
Congestive heart failure (NYHA classification III or higher)
Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before screening test
Positive for any of the following: anti-hepatitis C virus antibody (anti-HCV Ab); hepatitis B surface antigen (HBsAg); or human immunodeficiency virus (HIV)
Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc)
Using ESA, anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before screening test

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

ASP1517 low dose group

ASP1517 middle dose group

ASP1517 high dose group

Placebo group

Arm Description

Oral

Outcomes

Primary Outcome Measures

Rate of rise in Hb (g/dL/week) at Week 6

Secondary Outcome Measures

Percentage of cumulative number of responder patients

responder is defined as a Hb ≥10.0 g/dL and an increase in Hb by ≥1.0 g/dL

Percentage of visits at which patients maintain Hb between 10.0-12.0 g/dL after achieving Hb ≥10.0 g/dL for each patients

Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit

Change from baseline in Hb

Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests

Full Information

NCT ID

NCT01964196

First Posted

October 15, 2013

Last Updated

April 8, 2021

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01964196

Brief Title

ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

Official Title

ASP1517 Phase 2 Clinical Trial -A Multi-center, Randomized, Parallel Groups, Placebo-controlled, Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 17, 2013 (Actual)

Primary Completion Date

July 6, 2015 (Actual)

Study Completion Date

December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma 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 study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.

Detailed Description

To evaluate the safety and the dose-response of ASP1517 on Hemoglobin (Hb) correction in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently. Patients will receive ASP1517 three times a week (TIW) for first 6weeks. Patients may have the second-randomization to TIW dosing or once-a-week (QW) dosing at Week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.

6. Conditions and Keywords

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

Anemia in Chronic Kidney Disease Patients Not on Dialysis

Keywords

Chronic Renal Failure, Renal anemia, ASP1517

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASP1517 low dose group

Arm Type

Experimental

Arm Description

Oral

Arm Title

ASP1517 middle dose group

Arm Type

Experimental

Arm Description

Oral

Arm Title

ASP1517 high dose group

Arm Type

Experimental

Arm Description

Oral

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Oral

Intervention Type

Drug

Intervention Name(s)

ASP1517

Intervention Description

Oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Rate of rise in Hb (g/dL/week) at Week 6

Time Frame

Baseline and at 6 weeks after dosing

Secondary Outcome Measure Information:

Title

Percentage of cumulative number of responder patients

Description

responder is defined as a Hb ≥10.0 g/dL and an increase in Hb by ≥1.0 g/dL

Time Frame

for 28 weeks after dosing

Title

Percentage of visits at which patients maintain Hb between 10.0-12.0 g/dL after achieving Hb ≥10.0 g/dL for each patients

Time Frame

for 28 weeks after dosing

Title

Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit

Time Frame

Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28

Title

Change from baseline in Hb

Time Frame

Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28

Title

Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests

Time Frame

for 28 weeks after dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic kidney disease with an estimated glomerular filtration rate (as calculated by the Japanese GFR estimation equation) of =<89 mL/min/1.73 m2, and not required dialysis for 3 months since study completion The mean of two Hb values at screening test and Hb test (at least one week apart form the screening test) is <10.0 g/dL, with a difference of ≤1.0 g/dL between the two values Both TSAT>=5% and ferritin >=30 ng/mL at screening test Serum folate ≥4.0 ng/mL and Vitamin B12 ≥180 pg/mL at screening test Exclusion Criteria: Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, celiac disease, etc). Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or evidence of active gastroparesis. Uncontrollable hypertension (more than one third blood pressure values of diastolic BP >100 mmHg within 16 weeks prior to screening test including) Congestive heart failure (NYHA classification III or higher) Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before screening test Positive for any of the following: anti-hepatitis C virus antibody (anti-HCV Ab); hepatitis B surface antigen (HBsAg); or human immunodeficiency virus (HIV) Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc) Using ESA, anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before screening test

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Director

Facility Information:

City

Chubu

Country

Japan

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kanto

Country

Japan

City

Kyushu

Country

Japan

City

Shikoku

Country

Japan

City

Tohoku

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing URL

http://www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

36005278

Citation

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Results Reference

derived

PubMed Identifier

30953333

Citation

Akizawa T, Iwasaki M, Otsuka T, Reusch M, Misumi T. Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Adv Ther. 2019 Jun;36(6):1438-1454. doi: 10.1007/s12325-019-00943-4. Epub 2019 Apr 5.

Results Reference

derived

Links:

URL

https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=397

Description

Link to results on the Astellas Clinical Study Results website.

Learn more about this trial

ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

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