Samtidig påbegyndelse af de 4 guideline-styrede CKD-behandlinger (RAPID-CKD) (RAPID-CKD)
7. maj 2026 opdateret af: Baylor Research Institute
<string>Et pilot randomiseret klinisk forsøg til vurdering af gennemførlighed, sikkerhed og effektivitet af hurtig, samtidig behandlingsinitiering ved kronisk nyresygdom og type 2-diabetes: RAPID-CKD</string>
Formålet med denne undersøgelse er at afgøre, om det er sikkert og effektivt at starte alle fire kroniske nyresygdomsbehandlinger samtidig for patienter med type 2-diabetes og kronisk nyresygdom.
Undersøgelseshypotesen siger, at det er sikkert og effektivt at starte alle fire anbefalede nyremedicin samtidig med at reducere albuminuri, et protein i urinen, uden forringelse af nyrefunktionen eller stigning i kaliumniveauer sammenlignet med at starte én medicin ad gangen.
Undersøgelseshypotesen siger, at det er sikkert og effektivt at starte alle fire anbefalede nyremedicin samtidig med at reducere albuminuri, et protein i urinen, uden forringelse af nyrefunktionen eller stigning i kaliumniveauer sammenlignet med at starte én medicin ad gangen.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
- Medicin: Finerenon
- Medicin: Semaglutid
- Medicin: Lotensin
- Medicin: Capoten
- Medicin: Enalapril
- Medicin: Monopril
- Medicin: Lisinolpril
- Medicin: Univasc
- Medicin: Aceon
- Medicin: Accupril
- Medicin: Altace
- Medicin: Mavik
- Medicin: Edarbi
- Medicin: Atacand
- Medicin: Avapro
- Medicin: Cozaar
- Medicin: Benicar
- Medicin: Micardis
- Medicin: Diovan
- Medicin: Invokana
- Medicin: Farxiga
- Medicin: Jardiance
- Medicin: Ertugliflozin
- Medicin: Brenzavvy
- Medicin: Sotagliflozin
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
64
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Shahzeb Khan, MD
- Telefonnummer: 469-326-2636
- E-mail: shahzeb.khan@bswhealth.org
Studiesteder
-
-
Texas
-
Temple, Texas, Forenede Stater, 76508
- Baylor Scott and White Medical Center- Temple
-
Kontakt:
- Shahzeb Khan, MD
- Telefonnummer: 469-326-2636
- E-mail: shahzeb.khan@bswhealth.org
-
Ledende efterforsker:
- Shahzeb Khan, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:<\/p>
- Patienter i alderen 18-84 år<\/li>
- eGFR 45 til \u226490 mL\/min\/1,73 m2<\/li>
- UACR >200 mg\/g<\/li>
- diagnose af T2D30<\/li>
- i behandling med \u22642 anbefalede lægemiddelklasser uanset dosis i \u22654 uger før screening<\/li>
- egnet til alle 4 lægemidler<\/li>
- systolisk BT (SBT) >90 mmHg<\/li>
- personer, der er villige til at give skriftligt informeret samtykke og overholde studiebesøg.<\/li><\/ul>
Eksklusionskriterier:<\/p>
- Type 1-diabetes<\/li>
- enhver kendt primær ikke-diabetisk nyresygdom (dvs. polycystisk nyresygdom, glomerulonefritis, interstitiel nefritis osv.)<\/li>
- tidligere nyretransplantation<\/li>
- leversygdom (dvs. aspartataminotransferase eller alaninaminotransferase >5 gange, eller bilirubin >3 gange øvre grænse for normal)<\/li>
- serumkalium >5,5 mEq\/L ved baseline<\/li>
- kendt overfølsomhed over for et hvilket som helst studielægemiddel<\/li>
- forventet levetid <6 måneder<\/li>
- aktiv kræftsygdom eller infektion<\/li>
- brittle diabetes (defineret som alvorlig glykæmisk ustabilitet med hospitalsindlæggelse eller akut behandling for hypoglykæmi eller hyperglykæmi inden for de seneste 6 måneder)<\/li>
- høj risiko for hypoglykæmi (Clarke- eller Gold-score \u22654)31<\/li>
- forudsagt 12-måneders risiko for hypoglykæmi-relaterede akutbesøg eller hospitalsindlæggelser >5% ved brug af Kaiser Permanente hypoglykæmi-prædiktionsscore32,33<\/li>
- brug af højdosis insulin (>1 enhed\/kg\/dag).<\/li><\/ul>
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Interventionsgruppe
Forsøgspersoner modtager alle fire behandlinger mod kronisk nyresygdom (medicin) på samme tid.
|
10-40 mg dagligt
.25-1,0mg 1 gang om ugen
10-40 mg dagligt
Andre navne:
12,5-50 mg 3 gange dagligt
Andre navne:
2,5-10 mg dagligt
10-40 mg dagligt
Andre navne:
5-20 mg dagligt
3,75-15 mg dagligt
Andre navne:
4-16 mg dagligt
Andre navne:
10-40 mg dagligt
Andre navne:
1,25-5 mg dagligt
Andre navne:
1-4 mg dagligt
Andre navne:
40-80 mg dagligt
Andre navne:
8-32 mg dagligt
Andre navne:
150-300 mg dagligt
Andre navne:
25-100 mg dagligt
Andre navne:
20-40 mg dagligt
Andre navne:
20-80 mg dagligt
Andre navne:
80-320 mg dagligt
Andre navne:
100 mg dagligt
Andre navne:
10 mg dagligt
Andre navne:
10 mg dagligt
Andre navne:
5 mg dagligt
20 mg dagligt
Andre navne:
200-400 mg dagligt
Andre navne:
|
|
Aktiv komparator: Kontrolgruppe
Personer fik standardbehandling
|
10-40 mg dagligt
.25-1,0mg 1 gang om ugen
10-40 mg dagligt
Andre navne:
12,5-50 mg 3 gange dagligt
Andre navne:
2,5-10 mg dagligt
10-40 mg dagligt
Andre navne:
5-20 mg dagligt
3,75-15 mg dagligt
Andre navne:
4-16 mg dagligt
Andre navne:
10-40 mg dagligt
Andre navne:
1,25-5 mg dagligt
Andre navne:
1-4 mg dagligt
Andre navne:
40-80 mg dagligt
Andre navne:
8-32 mg dagligt
Andre navne:
150-300 mg dagligt
Andre navne:
25-100 mg dagligt
Andre navne:
20-40 mg dagligt
Andre navne:
20-80 mg dagligt
Andre navne:
80-320 mg dagligt
Andre navne:
100 mg dagligt
Andre navne:
10 mg dagligt
Andre navne:
10 mg dagligt
Andre navne:
5 mg dagligt
20 mg dagligt
Andre navne:
200-400 mg dagligt
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
On-study retention rate at 6 months
Tidsramme: 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%
Tidsramme: 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
Tidsramme: 6 months
|
Relative change in log-transformed urine albumin-to-creatinine ratio (UACR) from baseline to 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Enrollment rate
Tidsramme: 6 months
|
Number of participants enrolled per month
|
6 months
|
|
Protocol adherence
Tidsramme: 6 months
|
Proportion of participants initiating all four therapies within 8 weeks
|
6 months
|
|
Treatment discontinuation
Tidsramme: 6 months
|
Proportion of participants who permanently discontinue one or more therapies
|
6 months
|
|
Moderate Hyperkalemia
Tidsramme: 6 months
|
Incidence of potassium levels greater than 5.5 to less than or equal to 6.0 mmol/L
|
6 months
|
|
Severe Hyperkalemia
Tidsramme: 6 months
|
Incidence of potassium levels greater than 6.0 mmol/L
|
6 months
|
|
Acute Kidney Injury
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 6 months
|
Rate of change in estimated glomerular filtration rate over the 6-month study period
|
6 months
|
|
Change in glycated hemoglobin (HbA1c)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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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.
- Collins AJ, Li S, Gilbertson DT, Liu J, Chen SC, Herzog CA. Chronic kidney disease and cardiovascular disease in the Medicare population: Management of comorbidities in kidney disease in the 21st century: Anemia and bone disease. Kidney International. 2003 Nov 1;64:S24-31. doi:10.1046/j.1523-1755.64.s87.5.x. PubMed PMID: 14531770
- Khan MS, Rashid AM, Shafi T, Rangaswami J, Cherney DZI, Butler J. Residual Risk of Adverse Kidney and Cardiovascular Outcomes in Patients with Chronic Kidney Disease. Clin J Am Soc Nephrol. Published online December 17, 2024. doi:10.2215/CJN.0000000588. PubMed PMID: 39688924; PMCID: PMC11906004
- 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
- Cotter G, Davison B, Metra M, et al. Amended STRONG-HF study design. Eur J Heart Fail. 2021;23(11):1981-1982. doi:10.1002/ejhf.2348. PubMed PMID: 34529313
- Zaman S, Zaman SS, Scholtes T, et al. The mortality risk of deferring optimal medical therapy in heart failure: a systematic comparison against norms for surgical consent and patient information leaflets. Eur J Heart Fail. 2017;19(11):1401-1409. doi:10.1002/ejhf.838. PubMed PMID: 28597606; PMCID: PMC5726382
- Abdin A, Anker SD, Butler J, et al. 'Time is prognosis' in heart failure: time-to-treatment initiation as a modifiable risk factor. ESC Heart Fail. 2021;8(6):4444-4453. doi:10.1002/ehf2.13646. PubMed PMID: 34655282; PMCID: PMC8712849
- Rashid AM, Khan MS, Cherney DZI, et al. Rapid and Simultaneous Initiation of Guideline-Directed Kidney Therapies in Patients with CKD and Type 2 Diabetes. J Am Soc Nephrol. Published online May 6, 2025. doi:10.1681/ASN.0000000752. PubMed PMID: 40327845
- ElSayed NA, Aleppo G, Aroda VR, et al. 2. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes-2023 [published correction appears in Diabetes Care. 2023 May 1;46(5):1106. doi: 10.2337/dc23-er05.] [published correction appears in Diabetes Care. 2023 Sep 01;46(9):1715. doi: 10.2337/dc23-ad08.]. Diabetes Care. 2023;46(Suppl 1):S19-S40. doi:10.2337/dc23-S002. PubMed PMID: 36507649; PMCID: PMC9810477
- Rubin NT, Seaquist ER, Eberly L, Kumar A, Mangia S, Öz G, Moheet A. Relationship Between Hypoglycemia Awareness Status on Clarke/Gold Methods and Counterregulatory Response to Hypoglycemia. J Endocr Soc. 2022 Aug 1;6(9):bvac107. doi: 10.1210/jendso/bvac107. PMID: 35935070; PMCID: PMC9351372.
- Karter AJ, Warton EM, Lipska KJ, Ralston JD, Moffet HH, Jackson GG, Huang ES, Miller DR. Development and Validation of a Tool to Identify Patients With Type 2 Diabetes at High Risk of Hypoglycemia-Related Emergency Department or Hospital Use. JAMA Intern Med. 2017 Oct 1;177(10):1461-1470. doi: 10.1001/jamainternmed.2017.3844. PMID: 28828479; PMCID: PMC5624849.
- US Food and Drug Administration. Pragmatic Risk Score for Severe Hypoglycemic Events. Published October 28, 2021.
- Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012;65(3):301-308. doi:10.1016/j.jclinepi.2011.07.011. PubMed PMID: 22169081
- 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
- Fuhrman DY, Bagshaw SM, Goldstein SL, Legrand M, Shaw AD. Major adverse kidney events as an endpoint in acute kidney injury trials: is it time for a RE-MAKE?. Intensive Care Med. 2024;50(10):1723-1724. doi:10.1007/s00134-024-07602-5. PubMed PMID: 39145789; PMCID: PMC11446643
- Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW. Better outcomes for patients treated at hospitals that participate in clinical trials. Arch Intern Med. 2008;168(6):657-62. doi: 10.1001/archinternmed.2007.124. PubMed PMID: 18362259.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. april 2026
Primær færdiggørelse (Anslået)
31. marts 2029
Studieafslutning (Anslået)
31. marts 2029
Datoer for studieregistrering
Først indsendt
17. april 2026
Først indsendt, der opfyldte QC-kriterier
17. april 2026
Først opslået (Faktiske)
23. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Kronisk nyresygdom
- Type 2 diabetes
- Albuminuri
- Hyperkaliæmi
- Natrium-Glucose Cotransporter 2-hæmmere
- Vejledningsrettet medicinsk terapi
- Rapid Therapy Initiation
- Renin-Angiotensin System Inhibitors
- Non-steroidal Mineralocorticoid Receptor Antagonist
- Glucagon-Like Peptide-1 Receptor Agonist
- Estimated Glomerular Filtration Rate
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Sygdomme i det endokrine system
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Metaboliske sygdomme
- Vandladningsforstyrrelser
- Urologiske manifestationer
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Nyreinsufficiens
- Vand-elektrolyt ubalance
- Proteinuri
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Diabetes mellitus, type 2
- Nyreinsufficiens, kronisk
- Hyperkaliæmi
- Albuminuri
- Peptider
- Aminosyrer, peptider og proteiner
- Oligopeptider
- Svovlforbindelser
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Benzimidazoler
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Azoler
- Kulbrinter
- Kulbrinter, cyklisk
- Kulhydrater
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Glukosider
- Glycosider
- Imidazoler
- Indoler
- Aminosyrer
- Benzenderivater
- Organophosphorforbindelser
- Aminosyrer, essentielle
- Aminosyrer, cykliske
- Thiophener
- Tetrazoler
- Tetrahydroisoquinoliner
- Isoquinoliner
- Biphenylforbindelser
- Dipeptider
- Spiro -forbindelser
- Valine
- Aminosyrer, forgrenet kæde
- Prolin
- Iminosyrer
- Fosfinsyrer
- Valsartan
- Olmesartan Medoxomil
- Telmisartan
- Canagliflozin
- Irbesartan
- Quinapril
- (2S,3R,4R,5S,6R)-2-(4-chlor-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
- Ramipril
- Losartan
- Enalapril
- Lisinopril
- Captopril
- Perindopril
- Semaglutid
- Empagliflozin
- Ertugliflozin
- finereonon
- dapagliflozin
- Candesartan Cilexetil
- Azilsartan
- Bexagliflozin
- BenazePril
- olmesartan
- Fosinopril
- moexipril
- trandolapril
Andre undersøgelses-id-numre
- 026-271
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Data will become available after publication of the primary results and will remain available on Vivli for a minimum of 10 years.
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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