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Samtidig oppstart av de 4 retningslinjestyrt CKD-behandlingene (RAPID-CKD) (RAPID-CKD)

7. mai 2026 oppdatert av: Baylor Research Institute

En pilot randomisert klinisk studie for å vurdere gjennomførbarhet, sikkerhet og effekt av rask, samtidig behandlingsstart ved kronisk nyresykdom og type 2-diabetes: RAPID-CKD

Formålet med denne studien er å avgjøre om det er trygt og effektivt å starte alle fire behandlingene for kronisk nyresykdom samtidig hos pasienter med type 2-diabetes og kronisk nyresykdom. Studiens hypotese sier at å starte alle fire anbefalte nyremedisinene samtidig er trygt og effektivt for å redusere albuminuri, et protein i urinen, uten nedgang i nyrefunksjon eller økning i kaliumnivåer sammenlignet med å starte én medisin om gangen.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

64

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Texas
      • Temple, Texas, Forente stater, 76508
        • Baylor Scott and White Medical Center- Temple
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shahzeb Khan, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:<\/p>

  • Pasienter i alderen 18–84 år<\/li>
  • eGFR 45 til ≤90 mL/min/1,73 m2<\/li>
  • UACR >200 mg/g<\/li>
  • diagnose av T2D30<\/li>
  • behandles med ≤2 anbefalte medikamentklasser uavhengig av dose i ≥4 uker før screening<\/li>
  • kvalifisert for alle 4 legemidlene<\/li>
  • systolisk blodtrykk (SBT) >90 mmHg<\/li>
  • personer som er villige til å gi skriftlig informert samtykke og overholde studiebesøk.<\/li><\/ul>

    Eksklusjonskriterier:<\/p>

    • Type 1-diabetes<\/li>
    • enhver kjent primær non-diabetisk nyresykdom (f.eks. polycystisk nyresykdom, glomerulonefritt, interstitiell nefritt, etc.)<\/li>
    • historie med nyretransplantasjon<\/li>
    • leversykdom (f.eks. aspartataminotransferase eller alaninaminotransferase >5 ganger, eller bilirubin >3 ganger øvre normalgrense)<\/li>
    • serumkalium >5,5 mEq/L ved baseline<\/li>
    • kjent overfølsomhet overfor noen av studiemedikamentene<\/li>
    • forventet levealder <6 måneder<\/li>
    • aktiv malignitet eller infeksjon<\/li>
    • ustabil diabetes (definert som alvorlig glykemisk ustabilitet med sykehusinnleggelse eller akutthjelp for hypoglykemi eller hyperglykemi i løpet av de siste 6 månedene)<\/li>
    • høy risiko for hypoglykemi (Clarke- eller Gold-score ≥4)31<\/li>
    • forutsagt 12-månders risiko for hypoglykemi-relaterte akuttbesøk eller sykehusinnleggelser >5% ved bruk av Kaiser Permanente hypoglykemi prediksjonsscore32,33<\/li>
    • høy dose insulin (>1 enhet/kg/dag).<\/li><\/ul>

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Intervensjonsgruppe
Forsøkspersonene mottar alle fire behandlingene for kronisk nyresykdom (medisiner) samtidig.
Legemiddel: Finerenone
10-40 mg daglig
Legemiddel: Semaglutid
0.25-1.0 mg 1 gang per uke
Legemiddel: Lotensin
10-40 mg daglig
Andre navn:
  • Benazepril
Legemiddel: Capoten
12,5-50 mg 3 ganger daglig
Andre navn:
  • Kapotopril
Legemiddel: Enalapril
2,5-10 mg daglig
Legemiddel: Monopril
10-40 mg daglig
Andre navn:
  • Fosinopril
Legemiddel: Lisinopril
5-20 mg daglig
Legemiddel: Univasc
3,75-15 mg daglig
Andre navn:
  • Moexipril
Legemiddel: Aceon
4-16 mg daglig
Andre navn:
  • Perindopril
Legemiddel: Accupril
10-40 mg daglig
Andre navn:
  • Quinapril
Legemiddel: Altace
1,25-5 mg daglig
Andre navn:
  • Ramipril
Legemiddel: Mavik
1-4 mg daglig
Andre navn:
  • Trandolapril
Legemiddel: Edarbi
40–80 mg daglig
Andre navn:
  • Azilsartan
Legemiddel: Atacand
8-32 mg daglig
Andre navn:
  • Candesartancilexeti
Legemiddel: Avapro
150-300 mg daglig
Andre navn:
  • Irbesartan
Legemiddel: Cozaar
25-100 mg daglig
Andre navn:
  • Losartan
Legemiddel: Benicar
20-40 mg daglig
Andre navn:
  • Olmesartan
Legemiddel: Micardis
20-80 mg daglig
Andre navn:
  • Telmisartan
Legemiddel: Diovan
80-320 mg daglig
Andre navn:
  • Valsartan
Legemiddel: Invokana
100 mg daglig
Andre navn:
  • Kanagliflozin
Legemiddel: Farxiga
10 mg daglig
Andre navn:
  • Dapagliflozinpropandiol
Legemiddel: Jardiance
10 mg daglig
Andre navn:
  • Empagliflozin
Legemiddel: Ertugliflozin
5 mg daglig
Legemiddel: Brenzavvy
20 mg daglig
Andre navn:
  • Bexagliflozin
Legemiddel: Sotagliflozin
200–400 mg daglig
Andre navn:
  • SAR439954
Aktiv komparator: Kontrollgruppe
Forsøkspersonene fikk standard behandling
Legemiddel: Finerenone
10-40 mg daglig
Legemiddel: Semaglutid
0.25-1.0 mg 1 gang per uke
Legemiddel: Lotensin
10-40 mg daglig
Andre navn:
  • Benazepril
Legemiddel: Capoten
12,5-50 mg 3 ganger daglig
Andre navn:
  • Kapotopril
Legemiddel: Enalapril
2,5-10 mg daglig
Legemiddel: Monopril
10-40 mg daglig
Andre navn:
  • Fosinopril
Legemiddel: Lisinopril
5-20 mg daglig
Legemiddel: Univasc
3,75-15 mg daglig
Andre navn:
  • Moexipril
Legemiddel: Aceon
4-16 mg daglig
Andre navn:
  • Perindopril
Legemiddel: Accupril
10-40 mg daglig
Andre navn:
  • Quinapril
Legemiddel: Altace
1,25-5 mg daglig
Andre navn:
  • Ramipril
Legemiddel: Mavik
1-4 mg daglig
Andre navn:
  • Trandolapril
Legemiddel: Edarbi
40–80 mg daglig
Andre navn:
  • Azilsartan
Legemiddel: Atacand
8-32 mg daglig
Andre navn:
  • Candesartancilexeti
Legemiddel: Avapro
150-300 mg daglig
Andre navn:
  • Irbesartan
Legemiddel: Cozaar
25-100 mg daglig
Andre navn:
  • Losartan
Legemiddel: Benicar
20-40 mg daglig
Andre navn:
  • Olmesartan
Legemiddel: Micardis
20-80 mg daglig
Andre navn:
  • Telmisartan
Legemiddel: Diovan
80-320 mg daglig
Andre navn:
  • Valsartan
Legemiddel: Invokana
100 mg daglig
Andre navn:
  • Kanagliflozin
Legemiddel: Farxiga
10 mg daglig
Andre navn:
  • Dapagliflozinpropandiol
Legemiddel: Jardiance
10 mg daglig
Andre navn:
  • Empagliflozin
Legemiddel: Ertugliflozin
5 mg daglig
Legemiddel: Brenzavvy
20 mg daglig
Andre navn:
  • Bexagliflozin
Legemiddel: Sotagliflozin
200–400 mg daglig
Andre navn:
  • SAR439954

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Baylor Research Institute

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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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
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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
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  • 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
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  • 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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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. april 2026

Primær fullføring (Antatt)

31. mars 2029

Studiet fullført (Antatt)

31. mars 2029

Datoer for studieregistrering

Først innsendt

17. april 2026

Først innsendt som oppfylte QC-kriteriene

17. april 2026

Først lagt ut (Faktiske)

23. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 026-271

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere