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KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)

2021년 3월 10일 업데이트: Keryx Biopharmaceuticals

Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia

The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).

연구 개요

상태

완전한

정황

개입 / 치료

의약품: KRX-0502

상세 설명

This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.

연구 유형

중재적

등록 (실제)

206

단계

4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Arizona
  - Phoenix, Arizona, 미국, 85032
    - Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
- California
  - Chula Vista, California, 미국, 91910
    - California Institute of Renal Research
  - El Centro, California, 미국, 92243
    - California Institute of Renal Research
  - Poway, California, 미국, 92064
    - California Institute of Renal Research
- Colorado
  - Denver, Colorado, 미국, 80230
    - Denver Nephrologists, P.C.
- Florida
  - Miami, Florida, 미국, 33143
    - Miami Kidney Group
  - Miami, Florida, 미국, 33150
    - Kidney and Hypertension Specialists of Miami, P.A.
- Georgia
  - Augusta, Georgia, 미국, 30904
    - Southeastern Clinical Research Institute, LLC
  - Columbus, Georgia, 미국, 31904
    - Renal Associates, LLC
- Illinois
  - Chicago, Illinois, 미국, 60643
    - Research by Design, LLC
- Mississippi
  - Gulfport, Mississippi, 미국, 39501
    - South Mississippi Medical Research, LLC
- Missouri
  - Kansas City, Missouri, 미국, 64111
    - Clinical Research Consultants
- Nevada
  - Reno, Nevada, 미국, 89511
    - Sierra Nevada Nephrology Consultants
- New Jersey
  - Eatontown, New Jersey, 미국, 07724
    - Hypertension and Nephrology Association
- New York
  - Great Neck, New York, 미국, 11021
    - Division of Kidney/HTN Research
- North Carolina
  - Asheville, North Carolina, 미국, 28801
    - Mountain Kidney & Hypertension Associates
  - Charlotte, North Carolina, 미국, 28207
    - Metrolina Nephrology Associates, PA
  - Greenville, North Carolina, 미국, 27834
    - Eastern Nephrology Associates
  - Jacksonville, North Carolina, 미국, 28546
    - Southeastern Nephrology Associates
  - New Bern, North Carolina, 미국, 28562
    - Eastern Nephrology Associates
  - Wilmington, North Carolina, 미국, 28401
    - Southeastern Nephrology
- South Carolina
  - Columbia, South Carolina, 미국, 29203
    - Columbia Nephrology Associates, PA
  - Orangeburg, South Carolina, 미국, 29118
    - South Carolina Nephrology & Hypertension Center, Inc
- Tennessee
  - Nashville, Tennessee, 미국, 37205
    - Nephrology Associates, P.C.
- Texas
  - Austin, Texas, 미국, 78758
    - Research Management, Inc.
  - Austin, Texas, 미국, 78751
    - Research Management, Inc.
  - Lufkin, Texas, 미국, 75904
    - P & I Clinical Research, LLC
  - San Antonio, Texas, 미국, 78212
    - Clinical Advancement Center, PLLC

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
Hgb ≥8.5 g/dL and ≤11.5 g/dL
Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
Serum intact parathyroid hormone ≤600 pg/mL

Exclusion Criteria:

Serum phosphate <3.0 mg/dL
Intravenous (IV) iron administered within 4 weeks prior to Screening
Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
Blood transfusion within 4 weeks prior to Screening

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Group 1 KRX-0502 1 tablet thrice daily (TID) with meals	의약품: KRX-0502 Oral ferric citrate with meals 다른 이름들: 구연산철
실험적: Group 2 KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals	의약품: KRX-0502 Oral ferric citrate with meals 다른 이름들: 구연산철

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Change From Baseline in Hemoglobin (Hgb) at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 24

2차 결과 측정

결과 측정	측정값 설명	기간
Change From Baseline in Hgb at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 48
Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period 기간: from Randomization to Week 24	The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.	from Randomization to Week 24
Change From Baseline in Transferrin Saturation (TSAT) at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 24
Change From Baseline in TSAT at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 48
Change From Baseline in Ferritin at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 24
Change From Baseline in Ferritin at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 48
Change From Baseline in Serum Phosphate at Week 24 기간: Baseline; up to Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; up to Week 24
Change From Baseline in Serum Phosphate at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 48
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 24
Change From Baseline in eGFR at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 48
Change From Baseline in Bicarbonate at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 24
Change From Baseline in Bicarbonate at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.	Baseline; Week 48
Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.	Baseline; Week 24
Change From Baseline in iPTH at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.	Baseline; Week 48
Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.	Baseline; Week 24
Change From Baseline in C-terminal FGF23 at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.	Baseline; Week 48
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.	Baseline; Week 24
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.	Baseline; Week 48
Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.	Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.	Baseline; Week 48
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.	Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.	Baseline; Week 48
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24 기간: Baseline; Week 24	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.	Baseline; Week 24
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48 기간: Baseline; Week 48	Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.	Baseline; Week 48
Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period 기간: up to Week 48	A hospitalization is defined as admission to the hospital.	up to Week 48
Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period 기간: up to Week 48	A hospitalization is defined as admission to the hospital.	up to Week 48
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period 기간: up to Week 48	Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.	up to Week 48

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Keryx Biopharmaceuticals

수사관

연구 책임자: Medical Director, Keryx Biopharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 8월 15일

기본 완료 (실제)

2019년 8월 30일

연구 완료 (실제)

2019년 9월 27일

연구 등록 날짜

최초 제출

2017년 7월 26일

QC 기준을 충족하는 최초 제출

2017년 7월 31일

처음 게시됨 (실제)

2017년 8월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 3월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 3월 10일

마지막으로 확인됨

2021년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

KRX-0502-402

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 신장 질환에 대한 임상 시험

Hospital Clinic of Barcelona
AstraZeneca

완전한

TIcaGrEloR 및 ABSORB 생체흡수성 혈관 스캐폴드 이식으로 성공적인 만성 전폐쇄 재개통술 후 혈관 기능 회복 (TIGER-BVS)

CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자

스페인
Shanghai 10th People's Hospital

모병

만성신장질환의 다중오믹스 분석

CKD에서 Microbiota-Gut-Kidney Axis의 잠재적 메커니즘

중국
University Hospital, Basel, Switzerland

아직 모집하지 않음

스위스 심혈관-키드니-리버-대사 (CKLM) 레지스트리

심혈관-키드니-대사 증후군 | CRADIOVAST-KIDNEY-LIVER-Metabolic (CKLM) 증후군

스위스
University of Pennsylvania

완전한

심근경색 환자의 약물 순응도를 개선하기 위한 자동화된 호버링(Heartstrong) (Heartstrong)

Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)

미국

KRX-0502에 대한 임상 시험

Keryx Biopharmaceuticals
Collaborative Study Group (CSG)

완전한

말기 신장 질환(ESRD) 환자를 대상으로 한 Zerenex(구연산철)의 안전성 및 내약성 연구

고인산혈증 | 말기 신장 질환

미국
Keryx Biopharmaceuticals
Collaborative Study Group (CSG)

완전한

말기 신질환 환자에서 KRX-0502(구연산철)의 4주 용량 범위 및 효능 시험

말기 신장 질환 | 고인산혈증

미국, 푸에르토 리코
Keryx Biopharmaceuticals

완전한

말기 신질환 환자에 대한 KRX-0502(구연산철)의 신규 제제 임상시험

고인산혈증 | 말기 신장 질환 | 혈액 투석을 요하는 만성 신부전

이스라엘
Keryx Biopharmaceuticals

완전한

투석 중인 말기 신장 질환(ESRD) 환자에서 구연산철의 장기 안전성 연장 시험

신부전 | 말기 신장 질환 | ESRD | 신부전 | 고인산혈증

미국, 푸에르토 리코
Keryx Biopharmaceuticals

완전한

KRX-0502(Ferric Citrate, 음식 없이 투여하는 철 결핍성 빈혈 치료에 대한 파일럿 연구)

만성 신장 질환의 빈혈

이스라엘
Keryx Biopharmaceuticals

완전한

NDD-CKD 성인 피험자의 IDA 치료를 위한 KRX-0502(구연산철)

만성 신장 질환의 빈혈

미국
Keryx Biopharmaceuticals

완전한

투석을 받지 않는 빈혈 만성 신장 질환(CKD) 대상자의 혈청 인 및 철분 결핍을 관리하는 구연산철

철 결핍 성 빈혈 | 철분 결핍

미국
Keryx Biopharmaceuticals

정지된

만성신장질환과 관련된 고인산혈증 소아에서 구연산철의 안전성 및 내약성 평가를 위한 연구

만성 신장 질환과 관련된 고인산혈증

미국
InventisBio Co., Ltd

완전한

건강한 여성 피험자에서 D-0502 정제의 상대적 생체이용률 평가

건강한 여성 자원봉사자

미국
Keryx Biopharmaceuticals

완전한

투석 중인 ESRD 환자에 대한 구연산철의 58주 안전성 및 효능 시험

신부전 | 고인산혈증

미국, 이스라엘, 푸에르토 리코

KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)

Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (실제)

단계

연락처 및 위치

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

수사관

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (실제)

연구 완료 (실제)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

만성 신장 질환에 대한 임상 시험

KRX-0502에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Lithuania

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치