同时启动4种指南导向的CKD治疗（RAPID-CKD） (RAPID-CKD)
2026年5月7日 更新者：Baylor Research Institute
一项评估慢性肾脏病和2型糖尿病快速同时启动治疗的可行性、安全性和有效性的先导随机临床试验：RAPID-CKD
本研究的目的是确定对2型糖尿病合并慢性肾病患者同时启动所有四种慢性肾病治疗是否安全有效。研究假设假设，与每次启动一种药物相比，同时启动所有四种推荐肾脏药物能安全有效地减少白蛋白尿（尿液中的一种蛋白质），而不会导致肾功能下降或血钾水平升高。
研究概览
地位
尚未招聘
详细说明
This study is a pilot, open-label, randomized clinical trial designed to evaluate the feasibility, safety, and effectiveness of rapidly starting multiple guideline-recommended therapies in people with type 2 diabetes and chronic kidney disease.
In current clinical practice, these medicines are usually started one at a time over many months. This step-by-step approach may delay potential benefits and leave people at continued risk of kidney disease progression and cardiovascular complications. This study will test a different approach, where these therapies are started in a structured and closely monitored way over a short period of time.
Participants will be randomly assigned to either a rapid initiation strategy or usual care. In the rapid group, up to four approved therapies will be started and adjusted over approximately 8 weeks using a structured treatment plan. In the usual care group, treatment will follow standard clinical practice, where medications are introduced gradually at the discretion of the treating clinician.
Participants in both groups will be followed for 6 months. During this time, they will have regular clinic visits and laboratory testing to monitor kidney function, potassium levels, and overall treatment tolerance.
This pilot study will provide important information on whether this rapid treatment approach can be safely implemented in real-world clinical settings and whether participants are able to start and continue multiple therapies within a short time frame.
研究类型
介入性
注册 (估计的)
64
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shahzeb Khan, MD
- 电话号码：469-326-2636
- 邮箱：shahzeb.khan@bswhealth.org
学习地点
-
-
Texas
-
Temple、Texas、美国、76508
- Baylor Scott and White Medical Center- Temple
-
接触：
- Shahzeb Khan, MD
- 电话号码：469-326-2636
- 邮箱：shahzeb.khan@bswhealth.org
-
首席研究员：
- Shahzeb Khan, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 年龄在18-84岁的患者
- eGFR 45至≥90 mL/min/1.73 m2
- UACR >200 mg/g
- 确诊T2D30
- 在筛选前已接受≥2种指南推荐药物类别（不论剂量）≥4周
- 符合所有4种药物的使用条件
- 收缩压(SBP) >90 mmHg
- 愿意提供书面知情同意书并遵守研究访视。
排除标准：
- 1型糖尿病
- 任何已知的原发性非糖尿病肾病（即多囊肾病、肾小球肾炎、间质性肾炎等）
- 有肾移植史
- 肝病（即天冬氨酸转氨酶或丙氨酸转氨酶>正常上限5倍，或胆红素>正常上限3倍）
- 基线血清钾>5.5 mEq/L
- 对任何研究药物有已知的超敏反应
- 预期寿命<6个月
- 活动性恶性肿瘤或感染
- 脆性糖尿病（定义为过去6个月内因低血糖或高血糖导致住院或急诊的严重血糖不稳定）
- 低血糖高风险（Clarke或Gold评分≥4）31
- 使用Kaiser Permanente低血糖预测评分预测的12个月低血糖相关急诊就诊或住院风险>5%32,33
- 使用高剂量胰岛素（>1单位/kg/天）。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：干预组
受试者同时接受全部四种慢性肾病治疗方案（药物）。
|
每日10-40毫克
0.25-1.0mg每周1次
每日10-40毫克
其他名称：
12.5-50mg 每日3次
其他名称：
2.5-10mg每日
每日10-40毫克
其他名称：
5-20毫克每日
3.75-15毫克每日
其他名称：
每日4-16毫克
其他名称：
每日10-40mg
其他名称：
1.25-5mg 每日
其他名称：
每日1-4毫克
其他名称：
40-80毫克每日
其他名称：
每日8-32毫克
其他名称：
每日150-300mg
其他名称：
每日25-100毫克
其他名称：
20-40mg 每日
其他名称：
20-80毫克/天
其他名称：
每日80-320毫克
其他名称：
100mg 每日
其他名称：
10mg 每日一次
其他名称：
每日10毫克
其他名称：
5mg每日
20毫克每日
其他名称：
每日200-400毫克
其他名称：
|
|
有源比较器：对照组
受试者接受了标准治疗
|
每日10-40毫克
0.25-1.0mg每周1次
每日10-40毫克
其他名称：
12.5-50mg 每日3次
其他名称：
2.5-10mg每日
每日10-40毫克
其他名称：
5-20毫克每日
3.75-15毫克每日
其他名称：
每日4-16毫克
其他名称：
每日10-40mg
其他名称：
1.25-5mg 每日
其他名称：
每日1-4毫克
其他名称：
40-80毫克每日
其他名称：
每日8-32毫克
其他名称：
每日150-300mg
其他名称：
每日25-100毫克
其他名称：
20-40mg 每日
其他名称：
20-80毫克/天
其他名称：
每日80-320毫克
其他名称：
100mg 每日
其他名称：
10mg 每日一次
其他名称：
每日10毫克
其他名称：
5mg每日
20毫克每日
其他名称：
每日200-400毫克
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
On-study retention rate at 6 months
大体时间：6 months
|
Proportion of participants who remain on all four guideline-directed CKD therapies at maximally tolerated doses without permanent discontinuation
|
6 months
|
|
Sustained decline in eGFR ≥30%
大体时间：6 months
|
Proportion of participants with sustained decline in estimated glomerular filtration rate (eGFR; two consecutive readings ≥2 weeks apart)
|
6 months
|
|
Change in UACR
大体时间：6 months
|
Relative change in log-transformed urine albumin-to-creatinine ratio (UACR) from baseline to 6 months
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Enrollment rate
大体时间：6 months
|
Number of participants enrolled per month
|
6 months
|
|
Protocol adherence
大体时间：6 months
|
Proportion of participants initiating all four therapies within 8 weeks
|
6 months
|
|
Treatment discontinuation
大体时间：6 months
|
Proportion of participants who permanently discontinue one or more therapies
|
6 months
|
|
Moderate Hyperkalemia
大体时间：6 months
|
Incidence of potassium levels greater than 5.5 to less than or equal to 6.0 mmol/L
|
6 months
|
|
Severe Hyperkalemia
大体时间：6 months
|
Incidence of potassium levels greater than 6.0 mmol/L
|
6 months
|
|
Acute Kidney Injury
大体时间：6 months
|
Incidence of acute kidney injury (AKI) events (persistent estimated glomerular filtration rate decline ≥30% without return to <30% with drug discontinuation; or hospitalization with diagnosis of AKI related to medications) during the study period
|
6 months
|
|
End-stage kidney disease
大体时间：6 months
|
Incidence of progression to end-stage kidney disease (initiation of chronic dialysis [hemo- or peritoneal dialysis] for ≥90 days or kidney transplantation, or persistent [≥2 values, including the last value if not on dialysis or transplant] estimated glomerular filtration rate <15 mL/min/1.73m^2)
|
6 months
|
|
Number of participants with permanent drug discontinuation
大体时间：6 months
|
Number of participants with permanent discontinuation of one or more study drugs not due to study completion or death.
|
6 months
|
|
Rate of change in estimated glomerular filtration rate (slope)
大体时间：6 months
|
Rate of change in estimated glomerular filtration rate over the 6-month study period
|
6 months
|
|
Change in glycated hemoglobin (HbA1c)
大体时间：6 months
|
Change in glycated hemoglobin (HbA1c) levels from baseline
|
6 months
|
|
Number of participants who achieve >30% reduction in urine albumin-to-creatinine ratio
大体时间：6 months
|
Number of participants achieving >30% reduction in urine albumin-to-creatinine ratio
|
6 months
|
|
Change in Kidney Disease Quality of Life-36 score
大体时间：6 months
|
Change from baseline in Kidney Disease Quality of Life-36 (KDQOL-36) score.
Scores range from 0 to 100, with higher scores indicating better quality of life.
|
6 months
|
|
Change in Patient-Reported Outcomes Measurement Information System score
大体时间：6 months
|
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score.
PROMIS includes seven domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference.
Each domain includes 4 items scored from 1 to 5, with raw domain scores ranging from 4 to 20, and domain scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10.
A separate Pain Intensity item is rated on a 0 to 10 scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
For Physical Function and Ability to Participate in Social Roles and Activities, higher scores indicate better health.
For Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity, higher scores indicate greater symptom burden or worse health status.
|
6 months
|
|
Change in Treatment Burden Questionnaire (TBQ) score
大体时间：6 months
|
Change from baseline in Treatment Burden Questionnaire (TBQ) score.
TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem) to 10 (big problem) and assesses the burden associated with taking medicine, self-monitoring, laboratory tests, doctor visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment.
TBQ item scores can be summed into a global score, ranging from 0 to 130. Higher scores indicating greater treatment burden.
|
6 months
|
|
Change in Living with Medicines Questionnaire version 3 score
大体时间：6 months
|
Change from baseline in Living with Medicines Questionnaire version 3 (LMQ-3) score.
LMQ-3 consists of 41 items scored on a 5-point Likert scale.
Total scores range from 41 to 205, with higher scores indicating greater treatment burden.
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Dalrymple LS, Katz R, Kestenbaum B, et al. Chronic kidney disease and the risk of end-stage renal disease versus death. J Gen Intern Med. 2011;26(4):379-385. doi:10.1007/s11606-010-1511-x. PubMed PMID: 20853156; PMCID: PMC3055978.
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- Perkovic V, Tuttle KR, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024;391(2):109-121. doi:10.1056/NEJMoa2403347. PubMed PMID: 38785209
- Mayer GJ, Wanner C, Weir MR, et al. Analysis from the EMPA-REG OUTCOME® trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics. Kidney Int. 2019;96(2):489-504. doi:10.1016/j.kint.2019.02.033. PubMed PMID: 31142441
- Neuen BL, Oshima M, Perkovic V, et al. Effects of canagliflozin on serum potassium in people with diabetes and chronic kidney disease: the CREDENCE trial. Eur Heart J. 2021;42(48):4891-4901. doi:10.1093/eurheartj/ehab497. PubMed PMID: 34423370
- Brownell NK, Ziaeian B, Fonarow GC. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2021;7:e18. PubMed PMID: 34950508; PMCID: PMC8674626
- Lin CY, Hammash M, Miller JL, et al. Delay in seeking medical care for worsening heart failure symptoms: predictors and association with cardiac events. Eur J Cardiovasc Nurs. 2021;20(5):454-463. doi:10.1093/eurjcn/zvaa032. PubMed PMID: 33580784
- Adamo M, Pagnesi M, Mebazaa A, et al. NT-proBNP and high intensity care for acute heart failure: the STRONG-HF trial. Eur Heart J. 2023;44(31):2947-2962. doi:10.1093/eurheartj/ehad335. PubMed PMID: 37217188
- Greene SJ, Butler J, Fonarow GC. Simultaneous or Rapid Initiation of Combination Therapy for Heart Failure With Preserved Ejection Fraction. JAMA Cardiol. 2025 May 1;10(5):407-408. doi: 10.1001/jamacardio.2025.0038. PMID: 40042835.
- Neuen BL, Heerspink HJL, Vart P et al. Estimated lifetime cardiovascular, kidney, and mortality benefits of combination treatment with SGLT2 inhibitors, GLP-1 receptor agonists, and nonsteroidal MRA compared with conventional care in patients with type 2 diabetes and albuminuria. Circulation 2024;149:450-62. 10.1161/CIRCULATIONAHA.123.067584. PubMed PMID: 37952217.
- . Khan MS, Lea JP. Kidney and cardiovascular-protective benefits of combination drug therapies in chronic kidney disease associated with type 2 diabetes. BMC Nephrol. 2024;25(1):248. Published 2024 Aug 1. doi:10.1186/s12882-024-03652-5. PubMed PMID: 39090593; PMCID: PMC11293206
- Davies MJ, Aroda VR, Collins BS, et al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753-2786. doi:10.2337/dci22-0034. PubMed PMID: 36148880; PMCID: PMC10008140
- Agarwal R, Green JB, Heerspink HJL, et al. COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: Baseline clinical characteristics. Nephrol Dial Transplant. Published online February 7, 2025. doi:10.1093/ndt/gfaf022. PubMed PMID: 39916475
- Agarwal R. Defining end-stage renal disease in clinical trials: a framework for adjudication. Nephrol Dial Transplant. 2016;31(6):864-867. doi:10.1093/ndt/gfv289. PubMed PMID: 26264780
- Feng XS, Farej R, Dean BB, et al. CKD Prevalence Among Patients With and Without Type 2 Diabetes: Regional Differences in the United States. Kidney Med. 2021;4(1):100385. Published 2021 Nov 3. doi:10.1016/j.xkme.2021.09.003. PubMed PMID: 35072048; PMCID: PMC8767132
- Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. PMID: 38490803.
- An L, Wang D, Shi X, He Y, Lee Y, Lu J. Differences in prevalence and management of chronic kidney disease among T2DM inpatients at the grassroots in Beijing and Taiyuan: a retrospective study. J Health Popul Nutr. 2023 Jul 5;42(1):61. doi: 10.1186/s41043-023-00406-1. PMID: 37408009; PMCID: PMC10320918.
- Mottl AK, Nicholas SB. KDOQI Commentary on the KDIGO 2022 Update to the Clinical Practice Guideline for Diabetes Management in CKD. Am J Kidney Dis. 2024;83(3):277-287. doi:10.1053/j.ajkd.2023.09.003. PubMed PMID: 38142396
- Chaudhuri A, Ghanim H, Arora P. Improving the residual risk of renal and cardiovascular outcomes in diabetic kidney disease: A review of pathophysiology, mechanisms, and evidence from recent trials. Diabetes Obes Metab. 2022;24(3):365-376. doi:10.1111/dom.14601. PubMed PMID: 34779091; PMCID: PMC9300158
- Bansal N, Zelnick L, Bhat Z, et al. Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease. J Am Coll Cardiol. 2019;73(21):2691-2700. doi:10.1016/j.jacc.2019.02.071. PubMed PMID: 31146814; PMCID: PMC6590908
- Bell DSH, McGill JB, Jerkins T. Management of the 'wicked' combination of heart failure and chronic kidney disease in the patient with diabetes. Diabetes Obes Metab. 2023;25(10):2795-2804. doi:10.1111/dom.15181. PubMed PMID: 37409564
- Rivera E, Clark Cutaia MN, Schrauben SJ, et al. Treatment adherence in CKD and support from health care providers: a qualitative study. Kidney Med. 2022;4(11):100545. doi:10.1016/j.xkme.2022.100545. PubMed PMID: 36339664; PMCID: PMC9630784
- Čelutkienė J, Čerlinskaitė-Bajorė K, Cotter G, et al. Impact of Rapid Up-Titration of Guideline-Directed Medical Therapies on Quality of Life: Insights From the STRONG-HF Trial. Circ Heart Fail. 2024;17(4):e011221. doi:10.1161/CIRCHEARTFAILURE.123.011221. PubMed PMID: 38445950
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- Vaduganathan M, Filippatos G, Claggett BL, et al. Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes [published correction appears in Nat Med. 2024 Dec;30(12):3778. doi: 10.1038/s41591-024-03372-1]. Nat Med. 2024;30(12):3758-3764. doi:10.1038/s41591-024-03264-4. PMID: 39218030; PMCID: PMC11645272
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年4月30日
初级完成 (估计的)
2029年3月31日
研究完成 (估计的)
2029年3月31日
研究注册日期
首次提交
2026年4月17日
首先提交符合 QC 标准的
2026年4月17日
首次发布 (实际的)
2026年4月23日
研究记录更新
最后更新发布 (实际的)
2026年5月8日
上次提交的符合 QC 标准的更新
2026年5月7日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
- 泌尿生殖系统疾病
- 内分泌系统疾病
- 病理过程
- 男性泌尿生殖系统疾病
- 肾脏疾病
- 泌尿系统疾病
- 女性泌尿生殖系统疾病
- 女性泌尿生殖系统疾病和妊娠并发症
- 慢性病
- 疾病属性
- 代谢性疾病
- 排尿障碍
- 泌尿系统表现
- 葡萄糖代谢紊乱
- 糖尿病
- 肾功能不全
- 水电解质失衡
- 蛋白尿
- 病理状况、体征和症状
- 营养代谢疾病
- 体征和症状
- 2型糖尿病
- 肾功能不全，慢性
- 高钾血症
- 蛋白尿
- 肽
- 氨基酸，肽和蛋白质
- 寡肽
- 硫化合物
- 有机化学品
- 杂环化合物，1形
- 杂环化合物
- 苯甲酰唑
- 杂环化合物，2环
- 杂环化合物，融合环
- Azoles
- 碳氢化合物
- 碳氢化合物，循环
- 碳水化合物
- 碳氢化合物，芳香族
- 多环化合物
- 葡萄糖剂
- 糖苷
- 咪唑
- 吲哚
- 氨基酸
- 苯衍生物
- 有机磷化合物
- 氨基酸，必不可少的
- 氨基酸，环状
- 硫苯
- 四唑
- 四氢异喹啉
- 等喹啉
- 双苯基化合物
- 二肽
- 螺纹化合物
- Valine
- 氨基酸，分支链
- 脯氨酸
- 亚氨基酸
- 次膦酸
- 缬沙坦
- 奥美沙坦酯
- 替米沙坦
- 卡格列净
- 厄贝沙坦
- 喹那普利
- (2S,3R,4R,5S,6R)-2-(4-氯-3-(4-乙氧基苄基)苯基)-6-(甲硫基)四氢-2H-吡喃-3,4,5-三醇
- 雷米普利
- 洛沙坦
- 依那普利
- 赖诺普利
- 卡托普利
- Perindopril
- semaglutide
- empagliflozin
- Ertugliflozin
- 罚款
- Dapagliflozin
- Candesartan cilexetil
- Azilsartan
- Bexagliflozin
- 贝纳西epril
- 奥美沙坦
- 福辛普利
- 莫昔普利
- 群多普利
其他研究编号
- 026-271
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Individual participant data (IPD) that underlie the results reported in this study, after deidentification, will be shared. Shared data will include patient-level clinical and laboratory data, along with a data dictionary (README file) to facilitate interpretation.
Data will be made available through the Vivli data sharing platform. Prior to external sharing, all data will undergo internal review to ensure removal of identifiable information and compliance with institutional legal and ethical requirements.
Data will be available for a minimum of 10 years and access will be provided in accordance with participant informed consent and applicable regulatory and institutional policies.
IPD 共享时间框架
Data will become available after publication of the primary results and will remain available on Vivli for a minimum of 10 years.
IPD 共享访问标准
Access will be provided to qualified researchers through the Vivli data sharing platform.
Prior to sharing, all data will undergo internal review to ensure removal of identifiable information and compliance with institutional legal and ethical requirements.
Data sharing will be conducted in accordance with participant informed consent and applicable regulatory and institutional policies.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.