Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
2026년 6월 17일 업데이트: Jing Chen, University of Texas Southwestern Medical Center
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.
Successful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The investigators will conduct a randomized, open-label, outcome blinded mechanistic clinical trial in 60 adults with stage 3 chronic kidney disease (CKD) who have hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD).
The investigators will evaluate whether low-dose Colchicine (LoDoCo) improves coronary artery calcification (CAC) and mineral and bone disorders (MBD) over 12 months in patients with CKD, eGFR ≥30 to 59 mL/min/1.73 m², and urine albumin-to-creatinine ratio (uACR) ≥200 mg/g. Sixty participants with CKD stage 3 and increased risk of, or established, ASCVD will be randomized 1:1 to receive LoDoCo plus usual care or usual care alone. Primary outcomes include changes in Agaston scores assessed by cardiac computed tomography (CCT) from baseline to 12 months, second outcomes include changes in the individual biomarkers of MBD and vascular calcification (VC) from baseline and 12 months. Exploratory outcomes include changes in uACR, estimated glomerular filtration rate (eGFR), ankle-brachial index (ABI), and toe-brachial index (TBI). Safety and tolerability will also be evaluated. Participants will be followed at baseline, 6 months, and 12 months for data collection, with an in-person visit at 1 month for safety evaluation. Additional safety assessments for side effects may be conducted by phone at any time.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
60
단계
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Paola Lanza, MD
- 전화번호: 469-852-9550
- 이메일: paola.lanza@UTSouthwestern.edu
연구 연락처 백업
- 이름: Alexandra R Hartman
- 전화번호: 614-420-1186
- 이메일: RESOLVE-CKD@UTSouthwestern.edu
연구 장소
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern Medical Center
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수석 연구원:
- Jing Chen, MD
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연락하다:
- Paola Lanza, MD
- 전화번호: 469-852-9550
- 이메일: paola.lanza@UTSouthwestern.edu
-
연락하다:
- Alexandra R Hartman
- 전화번호: 214-645-8294
- 이메일: alexandra.hartman@UTSouthwestern.edu
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Men and women aged 18-<70 years of all race/ethnicity groups
- CKD stage 3 (estimated glomerular filtration rate (eGFR) >30 to 59 ml/min/1.73m2)
- Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
- Cardiac artery calcification (CAC) Agatston score ≥30
- Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
- Ability to provide informed consent.
Exclusion Criteria:
- Current Colchicine therapy
- Hepatic disease
- Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.
- Immunosuppression
- Current use of chemotherapy drugs or active cancer
- Pregnancy/breastfeeding
- Hospitalized within the past 6 months
- Allergic/intolerance to colchicine
- Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
- Human immunodeficiency virus (HIV) infection
- Gout attack ≥ 1 time per year
- Severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men)
- eGFR <30 ml/min/1.73m2
- uACR <200 mg/g
- White blood cell count (WBC) <3.0 x109/L
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
- Total bilirubin >2 x ULN
- Glucose >300mg/dl
- Uses nicotine products or other recreational drugs
- Unable to read or speak English
- Participant in other conflict clinical trial,
- Unable to complete the study measurements
- Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
- Unsafe to participate in this study per investigator's judgement.
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: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
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Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
다른 이름들:
Participants will receive usual care according to standard clinical practice and treating physician discretion.
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활성 비교기: Usual Care
Participants will receive usual care alone.
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Participants will receive usual care according to standard clinical practice and treating physician discretion.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Coronary Artery Calcification Agatston Scores
기간: Baseline, 12 months
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Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score.
Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden).
Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.
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Baseline, 12 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Coronary Artery Calcification Volume Scores
기간: Baseline, 12 months
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Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Cardiac Artery Calcification Mass Scores
기간: Baseline, 12 months
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Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Serum Klotho Levels
기간: Baseline, 6 months, 12 months
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Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Fetuin A Levels
기간: Baseline, 6 months, 12 months
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Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Serum Phosphate levels
기간: Baseline, 6 months, 12 months
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Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Serum Calcium Levels
기간: Baseline, 6 months, 12 months
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Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Parathyroid Hormone (PTH) levels
기간: Baseline, 6 months, 12 months
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Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
기간: Baseline, 6 months, 12 months
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Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Fibroblast Growth Factor 23 (FGF23) Levels
기간: Baseline, 6 months, 12 months
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Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
기간: Baseline, 6 months, 12 months
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Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Telopeptide of Type I Collagen (CTX)
기간: Baseline, 6 months, 12 months
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Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
기간: Baseline, 6 months, 12 months
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Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Sclerostin Levels
기간: Baseline, 6 months, 12 months
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Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Lumbar Spine Bone Mineral Density (BMD)
기간: Baseline, 12 months
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BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Hip Bone Mineral Density (BMD)
기간: Baseline, 12 months
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BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Radius Bone Mineral Density (BMD)
기간: Baseline, 12 months
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BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
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Baseline, 12 months
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Change in Interleukin-6 (IL-6) Levels
기간: Baseline, 6 months, 12 months
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Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
기간: Baseline, 6 months, 12 months
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Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Interleukin-17 (IL-17) Levels
기간: Baseline, 6 months, 12 months
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Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
기간: Baseline, 6 months, 12 months
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Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
기간: Baseline, 6 months, 12 months
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Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
|
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Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
기간: Baseline, 6 months, 12 months
|
eGFR values (mL/min/1.73m2)
will be calculated using the NKF-ASN CKD-Epi refit formula.
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Baseline, 6 months, 12 months
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Exploratory: Change in Ankle-Brachial Index (ABI)
기간: Baseline, 6 months, 12 months
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ABI will be measured using semi-automated validated device (simpleABI-600CL).
ABI values range from ≤0.90 (Peripheral artery disease), 0.91-0.99
(borderline), 1.00-1.40
(normal).
ABI values >1.40 indicate non-compressible arteries, suggestive of arterial stiffness or medial calcification.
Both ABI values ≤0.90 and >1.40 are associated with worse outcomes.
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Baseline, 6 months, 12 months
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Exploratory: Change in Toe-Brachial Index (TBI)
기간: Baseline, 6 months, 12 months
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TBI will be measured using semi-automated validated device (simpleABI-600CL).
TBI values range from ≥0.70 (normal), 0.64-0.69
(borderline), and <0.40-0.50
(severe distal arterial disease/critical ischemia range).
TBI values <0.70 is a commonly used threshold suggestive of peripheral artery disease.
Lower TBI values are associated with worse outcomes.
|
Baseline, 6 months, 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Jing Chen, MD, University of Texas
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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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 (추정된)
연구 시작
2026년 7월 1일
기본 완료 (추정된)
기본 완료
2027년 12월 1일
연구 완료 (추정된)
연구 완료
2027년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 17일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 내분비계 질환
- 뼈 질환
- 근골격계 질환
- 혈관 질환
- 심혈관 질환
- 병리학적 과정
- 영양 장애
- 남성 비뇨 생식기 질환
- 신장 질환
- 비뇨기과 질환
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 만성 질환
- 질병 속성
- 대사 질환
- 포도당 대사 장애
- 신부전
- 뼈 질환, 대사
- 부갑상선 질환
- 지질 대사 장애
- 동맥 경화증
- 동맥 폐색 질환
- 비타민제
- 결핍증
- 영양 실조
- 구루병
- 칼슘 대사 장애
- 비타민 D 결핍
- 석회화
- 부갑상선기능항진증, 속발성
- 부갑상선기능항진증
- 병리학적 상태, 징후 및 증상
- 영양 및 대사 질환
- 고혈압
- 진성 당뇨병
- 신부전, 만성
- 이상지질혈증
- 죽상동맥경화증
- 혈관석회화
- 만성 신장 질환-미네랄 및 뼈 장애
- 이종 사이 클릭 화합물
- 알칼로이드
- 콜히친
기타 연구 ID 번호
기타 연구 ID 번호
- STU20260896
- 99077 (기타 식별자: UT Southwestern Medical Center)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
IRB approval is required before sharing IPD.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
예
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. .