Diabetic Kidney Disease (DKD)RIC-DKDNCT06654921
Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease
A study testing Remote ischemic conditioning and Standard medication therapy in people with Diabetic Kidney Disease (DKD), run by Capital Medical University.
Trial summary
Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- What is being tested?
- Remote ischemic conditioning and Standard medication therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of type 2 diabetes and receiving at least 1 antidiabetic medication
- CKD at stage G3 or G4 (eGFR = 15-60 mL/min/1.73 m2)
- UACR ≥ 300 mg/g or urinary albumin excretion rate (UAER) ≥ 300 mg/24 h
- Patients are cognitively and physically capable and willing to interact with the device and perform self-measurements
- Ability to withstand 5 full minutes of cuff inflation during prescreening
Who cannot join
- Patients with New York Heart Association Class III or IV congestive heart failure at enrollment
- Patients with severe illness with an expected lifespan of less than 6 months
- Patients with a recent history (< 6 months) of continuous renal replacement therapy, malignant tumor, myocardial infarction, acute coronary syndrome, stroke, seizure, thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism), or a cerebrovascular accident
- Patients with known severe arterial disease of the extremities (ulcers, amputations, known symptomatic peripheral arterial disease)
- Patients at imminent risk of starting dialysis during the study period
- Patients residing in a long-term care facility
- Patients in another interventional trial that could influence the intervention or outcome of this trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease: a Single-center Double-blinded Randomized Controlled Study
Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Approximately 10% of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive. Moreover, DKD progresses particularly rapidly and has a poor prognosis, accounting for almost 50% of end-stage renal disease (ESRD) cases. Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs. Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings . In the renal setting, RIP performed in dialysis patients is known to abrogate brain, heart and liver ischemia occurring during hemodialysis treatments. RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury. However, whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study.
Our overarching hypothesis is that RIP, performed in DKD patients, could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney. The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD.
Read the detailed description
Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Approximately 10% of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive. Moreover, DKD progresses particularly rapidly and has a poor prognosis, accounting for almost 50% of end-stage renal disease (ESRD) cases. Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs. Strategies to prevent progression to renal failure focus on exquisite blood pressure control, renin-angiotensin-aldosterone system (RAAS) inhibition for proteinuria DKD, and glycemic control with the use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in patients with diabetes. Even so, despite the optimization of these parameters, many high-risk DKD patients will progress to renal failure. Recurrent ischemic damage to the failing and fibrotic kidney appears to be one of the final common pathways of progressive kidney damage in late-stage DKD, irrespective of the original cause of kidney disease. Specific strategies to alter this pathway in DKD have not yet been developed. In this context, it is crucial to seek novel pharmaceutical or nonpharmaceutical approaches to optimize the treatment of DKD.
With the progression of DKD, renal interstitial fibrosis intensifies, leading to severe ischemia and hypoxia of kidney cells and ultimately leading to ESRD. Therefore, effectively delaying the process of renal fibrosis can slow or even reverse the process of DKD. Hypoxia is characterized by an insufficient supply of oxygen to organs, and hypoxia-inducible factor (HIF) regulates gene transcription in hypoxia. Appropriate renal hypoxia can activate HIF-1α and suppress HIF-2α, improving the ability of the kidney to adapt to hypoxia, reducing transforming growth factor (TGF)-β pathway activity and further inhibiting fibrosis development. Therefore, increasing the expression of HIF-1 in renal tissue may be a new method to delay renal interstitial fibrosis and the progression of DKD to ESRD. Previous studies have provided evidence that HIF-1α participates in remote ischemic preconditioning (RIP). HIF-1α levels are significantly increased in the peripheral blood after RIP is implemented. Therefore, we speculated that RIP may have a therapeutic effect on DKD.
Ischemic conditioning occurs when a transient episode of ischemia reduces the effect of a subsequent larger ischemic insult. Similar levels of protection can be achieved by RIP. RIP is a noninvasive physical therapy that induces remote vital organs to adapt to ischemia through repeated, short-term ischemia-reperfusion training on nonvital organs such as limbs, thereby improving their tolerance to ischemic injury and enabling them to withstand subsequent fatal ischemic events. Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings. In the renal setting, RIP performed in dialysis patients is known to abrogate brain, heart and liver ischemia occurring during hemodialysis treatments. RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury. However, whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study.
Our overarching hypothesis is that RIP, performed in DKD patients, could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney. The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD.
- Conditions
- Diabetic Kidney Disease (DKD)
- Being tested
- Remote ischemic conditioning, Sham remote ischemic conditioning, Standard medication therapy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
Also called RIC
RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.
Sham remote ischemic conditioningDevice
Also called Sham RIC
Sham RIC will be performed by the same electric auto-control device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (60 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.
Standard medication therapyDrug
Standard medication therapy will be performed according to the national and international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment. Receives: Device: Remote ischemic conditioning; Drug: Standard medication therapy |
| Sham group | Sham comparator | Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment. Receives: Device: Sham remote ischemic conditioning; Drug: Standard medication therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The tolerability of RIC in patients with DKD
Patients who complete at least of twice a day up to 5 months of RIC treatment are considered to be tolerable of RIC.
Measured: 0-6 months
Secondary outcomes (12)
ΔSerum creatinine
Changes of serum creatinine before and after the intervention. Serum creatinine is one of biomarkers of CKD progression, which is tested in fasting serum.
Measured: 0-6 months
ΔSerum Cystatin C
Changes of serum Cystatin C before and after the intervention. Serum Cystatin C is one of biomarkers of CKD progression, which is tested in fasting serum.
Measured: 0-6 months
ΔHemoglobin
Changes of hemoglobin before and after the intervention. Hemoglobin is used to evaluate renal anemia in CKD patients.
Measured: 0-6 months
ΔSerum KIM-1
Changes of serum KIM-1 before and after the intervention. Serum kidney injury molecule-1 (KIM-1) is the biomarker of renal tubule injury.
Measured: 0-6 months
ΔUrine microalbumin-creatinine ratio
Changes of urine microalbumin-creatinine ratio before and after the intervention. Urine microalbumin-creatinine ratio is the diagnostic as well as the disease progression biomarker of CKD.
Measured: 0-6 months
ΔEstimated glomerular filtration rate
Changes of Estimated glomerular filtration rate before and after the intervention. Estimated glomerular filtration rate is calculated using the CKD-EPI equation by serum creatinine and Cystatin C.
Measured: 0-6 months
ΔSerum VEGF
Changes of serum VEGF before and after the intervention. Serum vascular endothelial growth factor (VEGF) is related to the mechanism of RIC.
Measured: 0-6 months
ΔSerum HIF-1
Changes of serum HIF-1 before and after the intervention. Hypoxia inducible factor-1 (HIF-1) is related to the mechanism of RIC and CKD progression.
Measured: 0-6 months
Δurine protein
Changes o furine protein before and after the intervention. Urine protein is related to the mechanism of RIC and CKD progression.
Measured: 0-6 months
Incidence of major adverse cerebral and cardiac events
Myocardial infarction or stroke will be evaluated by professional investigators.
Measured: 0-6 months
Incidence of Kidney failure
Clinical outcome; to observe the proportion of patients who requires dialysis or transplantation.
Measured: 0-6 months
Incidence of all-cause death
Clinical outcome; to observe the proportion of all patients who died in each group.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654921
- Sponsor's protocol ID
- RIC-DKD
- Acronym
- RIC-DKD
- Status last verified
- Oct 2024
- First submitted
- 3 Jul 2021
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bello AK, Levin A, Tonelli M, Okpechi IG, Feehally J, Harris D, Jindal K, Salako BL, Rateb A, Osman MA, Qarni B, Saad S, Lunney M, Wiebe N, Ye F, Johnson DW. Assessment of Global Kidney Health Care Status. JAMA. 2017 May 9;317(18):1864-1881. doi: 10.1001/jama.2017.4046.
PubMed 28430830Wakashima T, Tanaka T, Fukui K, Komoda Y, Shinozaki Y, Kobayashi H, Matsuo A, Nangaku M. JTZ-951, an HIF prolyl hydroxylase inhibitor, suppresses renal interstitial fibroblast transformation and expression of fibrosis-related factors. Am J Physiol Renal Physiol. 2020 Jan 1;318(1):F14-F24. doi: 10.1152/ajprenal.00323.2019. Epub 2019 Oct 21.
PubMed 31630548Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
PubMed 29042490Ekeloef S, Homilius M, Stilling M, Ekeloef P, Koyuncu S, Munster AB, Meyhoff CS, Gundel O, Holst-Knudsen J, Mathiesen O, Gogenur I. The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial. BMJ. 2019 Dec 4;367:l6395. doi: 10.1136/bmj.l6395.
PubMed 31801725Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.
PubMed 26024502Li H, Satriano J, Thomas JL, Miyamoto S, Sharma K, Pastor-Soler NM, Hallows KR, Singh P. Interactions between HIF-1alpha and AMPK in the regulation of cellular hypoxia adaptation in chronic kidney disease. Am J Physiol Renal Physiol. 2015 Sep 1;309(5):F414-28. doi: 10.1152/ajprenal.00463.2014. Epub 2015 Jul 1.
PubMed 26136559Wang L, Jia L, Huang S, Ren C, Yu Y, Wang Y, Zhao W, Ji X, Li S. Safety and efficacy of remote ischaemic preconditioning in diabetic kidney disease: a pilot randomised, parallel-arm, sham-controlled trial protocol. BMJ Open. 2025 Sep 3;15(9):e096851. doi: 10.1136/bmjopen-2024-096851.
PubMed 40903083
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease: a Single-center Double-blinded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06654921
- Acronym / sponsor ID
- RIC-DKD / RIC-DKD
- Conditions
- Diabetic Kidney Disease (DKD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Approximately 10% of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive. Moreover, DKD progresses particularly rapidly and has a poor prognosis, accounting for almost 50% of end-stage renal disease (ESRD) cases. Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs. Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings . In the renal setting, RIP performed in dialysis patients is known to abrogate brain, heart and liver ischemia occurring during hemodialysis treatments. RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury. However, whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study.
Our overarching hypothesis is that RIP, performed in DKD patients, could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney. The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD.
Detailed description
Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Approximately 10% of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive. Moreover, DKD progresses particularly rapidly and has a poor prognosis, accounting for almost 50% of end-stage renal disease (ESRD) cases. Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs. Strategies to prevent progression to renal failure focus on exquisite blood pressure control, renin-angiotensin-aldosterone system (RAAS) inhibition for proteinuria DKD, and glycemic control with the use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in patients with diabetes. Even so, despite the optimization of these parameters, many high-risk DKD patients will progress to renal failure. Recurrent ischemic damage to the failing and fibrotic kidney appears to be one of the final common pathways of progressive kidney damage in late-stage DKD, irrespective of the original cause of kidney disease. Specific strategies to alter this pathway in DKD have not yet been developed. In this context, it is crucial to seek novel pharmaceutical or nonpharmaceutical approaches to optimize the treatment of DKD.
With the progression of DKD, renal interstitial fibrosis intensifies, leading to severe ischemia and hypoxia of kidney cells and ultimately leading to ESRD. Therefore, effectively delaying the process of renal fibrosis can slow or even reverse the process of DKD. Hypoxia is characterized by an insufficient supply of oxygen to organs, and hypoxia-inducible factor (HIF) regulates gene transcription in hypoxia. Appropriate renal hypoxia can activate HIF-1α and suppress HIF-2α, improving the ability of the kidney to adapt to hypoxia, reducing transforming growth factor (TGF)-β pathway activity and further inhibiting fibrosis development. Therefore, increasing the expression of HIF-1 in renal tissue may be a new method to delay renal interstitial fibrosis and the progression of DKD to ESRD. Previous studies have provided evidence that HIF-1α participates in remote ischemic preconditioning (RIP). HIF-1α levels are significantly increased in the peripheral blood after RIP is implemented. Therefore, we speculated that RIP may have a therapeutic effect on DKD.
Ischemic conditioning occurs when a transient episode of ischemia reduces the effect of a subsequent larger ischemic insult. Similar levels of protection can be achieved by RIP. RIP is a noninvasive physical therapy that induces remote vital organs to adapt to ischemia through repeated, short-term ischemia-reperfusion training on nonvital organs such as limbs, thereby improving their tolerance to ischemic injury and enabling them to withstand subsequent fatal ischemic events. Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings. In the renal setting, RIP performed in dialysis patients is known to abrogate brain, heart and liver ischemia occurring during hemodialysis treatments. RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury. However, whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study.
Our overarching hypothesis is that RIP, performed in DKD patients, could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney. The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioning, Drug: Standard medication therapySubjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment. |
| Sham group | Sham comparator | Device: Sham remote ischemic conditioning, Drug: Standard medication therapySubjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of type 2 diabetes and receiving at least 1 antidiabetic medication
- CKD at stage G3 or G4 (eGFR = 15-60 mL/min/1.73 m2)
- UACR ≥ 300 mg/g or urinary albumin excretion rate (UAER) ≥ 300 mg/24 h
- Patients are cognitively and physically capable and willing to interact with the device and perform self-measurements
- Ability to withstand 5 full minutes of cuff inflation during prescreening
Key exclusion criteria (7 listed)
- Patients with New York Heart Association Class III or IV congestive heart failure at enrollment
- Patients with severe illness with an expected lifespan of less than 6 months
- Patients with a recent history (< 6 months) of continuous renal replacement therapy, malignant tumor, myocardial infarction, acute coronary syndrome, stroke, seizure, thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism), or a cerebrovascular accident
- Patients with known severe arterial disease of the extremities (ulcers, amputations, known symptomatic peripheral arterial disease)
- Patients at imminent risk of starting dialysis during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningAlso: RICRIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment. | Device | RIC group |
| Sham remote ischemic conditioningAlso: Sham RICSham RIC will be performed by the same electric auto-control device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (60 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment. | Device | Sham group |
| Standard medication therapyStandard medication therapy will be performed according to the national and international guidelines. | Drug | RIC group, Sham group |
Primary outcome
The tolerability of RIC in patients with DKD
Time frame: 0-6 months
Patients who complete at least of twice a day up to 5 months of RIC treatment are considered to be tolerable of RIC.
12 secondary outcomes
ΔSerum creatinine
Time frame: 0-6 months
ΔSerum Cystatin C
Time frame: 0-6 months
ΔHemoglobin
Time frame: 0-6 months
ΔSerum KIM-1
Time frame: 0-6 months
ΔUrine microalbumin-creatinine ratio
Time frame: 0-6 months
ΔEstimated glomerular filtration rate
Time frame: 0-6 months
ΔSerum VEGF
Time frame: 0-6 months
ΔSerum HIF-1
Time frame: 0-6 months
Δurine protein
Time frame: 0-6 months
Incidence of major adverse cerebral and cardiac events
Time frame: 0-6 months
Incidence of Kidney failure
Time frame: 0-6 months
Incidence of all-cause death
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 28430830Bello AK, Levin A, Tonelli M, Okpechi IG, Feehally J, Harris D, Jindal K, Salako BL, Rateb A, Osman MA, Qarni B, Saad S, Lunney M, Wiebe N, Ye F, Johnson DW. Assessment of Global Kidney Health Care Status. JAMA. 2017 May 9;317(18):1864-1881. doi: 10.1001/jama.2017.4046.
- Background: PubMed 31630548Wakashima T, Tanaka T, Fukui K, Komoda Y, Shinozaki Y, Kobayashi H, Matsuo A, Nangaku M. JTZ-951, an HIF prolyl hydroxylase inhibitor, suppresses renal interstitial fibroblast transformation and expression of fibrosis-related factors. Am J Physiol Renal Physiol. 2020 Jan 1;318(1):F14-F24. doi: 10.1152/ajprenal.00323.2019. Epub 2019 Oct 21.
- Background: PubMed 29042490Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
- Background: PubMed 31801725Ekeloef S, Homilius M, Stilling M, Ekeloef P, Koyuncu S, Munster AB, Meyhoff CS, Gundel O, Holst-Knudsen J, Mathiesen O, Gogenur I. The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial. BMJ. 2019 Dec 4;367:l6395. doi: 10.1136/bmj.l6395.
- Background: PubMed 26024502Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.
- Background: PubMed 26136559Li H, Satriano J, Thomas JL, Miyamoto S, Sharma K, Pastor-Soler NM, Hallows KR, Singh P. Interactions between HIF-1alpha and AMPK in the regulation of cellular hypoxia adaptation in chronic kidney disease. Am J Physiol Renal Physiol. 2015 Sep 1;309(5):F414-28. doi: 10.1152/ajprenal.00463.2014. Epub 2015 Jul 1.
- Derived from this study: PubMed 40903083Wang L, Jia L, Huang S, Ren C, Yu Y, Wang Y, Zhao W, Ji X, Li S. Safety and efficacy of remote ischaemic preconditioning in diabetic kidney disease: a pilot randomised, parallel-arm, sham-controlled trial protocol. BMJ Open. 2025 Sep 3;15(9):e096851. doi: 10.1136/bmjopen-2024-096851.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning and Standard medication therapy in people with Diabetic Kidney Disease (DKD), run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD, PhD (010-83199430, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The tolerability of RIC in patients with DKD (time frame: 0-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06654921, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.