Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
2026年6月17日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Paola Lanza, MD
- 電話番号：469-852-9550
- メール：paola.lanza@UTSouthwestern.edu
研究連絡先のバックアップ
- 名前：Alexandra R Hartman
- 電話番号：614-420-1186
- メール：RESOLVE-CKD@UTSouthwestern.edu
研究場所
-
-
Texas
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Dallas、Texas、アメリカ、75390
- University of Texas Southwestern Medical Center
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主任研究者：
- Jing Chen, MD
-
コンタクト：
- Paola Lanza, MD
- 電話番号：469-852-9550
- メール：paola.lanza@UTSouthwestern.edu
-
コンタクト：
- Alexandra R Hartman
- 電話番号：214-645-8294
- メール：alexandra.hartman@UTSouthwestern.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
|
Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
他の名前：
Participants will receive usual care according to standard clinical practice and treating physician discretion.
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アクティブコンパレータ：Usual Care
Participants will receive usual care alone.
|
Participants will receive usual care according to standard clinical practice and treating physician discretion.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Coronary Artery Calcification Agatston Scores
時間枠：Baseline, 12 months
|
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.
|
Baseline, 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Coronary Artery Calcification Volume Scores
時間枠：Baseline, 12 months
|
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
時間枠：Baseline, 12 months
|
Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
|
Baseline, 12 months
|
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Change in Serum Klotho Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Fetuin A Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
|
Baseline, 6 months, 12 months
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Change in Serum Phosphate levels
時間枠：Baseline, 6 months, 12 months
|
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
時間枠：Baseline, 6 months, 12 months
|
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Parathyroid Hormone (PTH) levels
時間枠：Baseline, 6 months, 12 months
|
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
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Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Fibroblast Growth Factor 23 (FGF23) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in C-terminal Telopeptide of Type I Collagen (CTX)
時間枠：Baseline, 6 months, 12 months
|
Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
|
Baseline, 6 months, 12 months
|
|
Change in Sclerostin Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Lumbar Spine Bone Mineral Density (BMD)
時間枠：Baseline, 12 months
|
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)
時間枠：Baseline, 12 months
|
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)
時間枠：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
|
Baseline, 12 months
|
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Change in Interleukin-6 (IL-6) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Interleukin-17 (IL-17) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
時間枠：Baseline, 6 months, 12 months
|
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
時間枠：Baseline, 6 months, 12 months
|
Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
時間枠：Baseline, 6 months, 12 months
|
eGFR values (mL/min/1.73m2)
will be calculated using the NKF-ASN CKD-Epi refit formula.
|
Baseline, 6 months, 12 months
|
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Exploratory: Change in Ankle-Brachial Index (ABI)
時間枠：Baseline, 6 months, 12 months
|
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.
|
Baseline, 6 months, 12 months
|
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Exploratory: Change in Toe-Brachial Index (TBI)
時間枠：Baseline, 6 months, 12 months
|
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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jing Chen, MD、University of Texas
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研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年6月11日
QC基準を満たした最初の提出物
2026年6月11日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 泌尿生殖器疾患
- 内分泌系疾患
- 骨の病気
- 筋骨格疾患
- 血管疾患
- 心血管疾患
- 病理学的プロセス
- 栄養障害
- 男性の泌尿生殖器疾患
- 腎臓病
- 泌尿器疾患
- 女性の泌尿生殖器疾患
- 女性の泌尿生殖器疾患と妊娠合併症
- 慢性疾患
- 疾患の属性
- 代謝疾患
- グルコース代謝障害
- 腎不全
- 骨疾患、代謝
- 副甲状腺疾患
- 脂質代謝異常症
- 動脈硬化
- 動脈閉塞性疾患
- ビタミン欠乏症
- 欠乏症
- 栄養失調
- くる病
- カルシウム代謝障害
- ビタミンD欠乏症
- 石灰沈着症
- 二次性副甲状腺機能亢進症
- 副甲状腺機能亢進症
- 病理学的状態、徴候および症状
- 栄養および代謝疾患
- 高血圧症
- 糖尿病
- 腎不全、慢性
- 脂質異常症
- アテローム性動脈硬化症
- 血管石灰化
- 慢性腎臓病 - ミネラルと骨の障害
- 複素環化化合物
- アルカロイド
- コルヒチン
その他の研究ID番号
- STU20260896
- 99077 (その他の識別子：UT Southwestern Medical Center)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
IRB approval is required before sharing IPD.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。