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A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial) (REMODEL)

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ClinicalTrials.gov Identifier: NCT04865770
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys.

Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment participants get is decided by chance.

Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes.

Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine into the skin once a week.

The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations.

Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours.

The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a detailed picture of organs and other parts inside the body. The scan will last for 30 minutes, and is free of radiation.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Chronic Kidney Disease Drug: Semaglutide Drug: Placebo (Semaglutide) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : June 8, 2023
Estimated Study Completion Date : January 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide 1.0 mg OW
Once-weekly (OW) Semaglutide administered subcutaneously (s.c., under the skin).
Drug: Semaglutide
Semaglutide given subcutaneously (sc, under the skin) once weekly. Dose gradually increased over 8 weeks from 0.25 to 1.0 mg. The study will last for about 1 year.

Placebo Comparator: Placebo (Semaglutide) 1.0 mg OW
Once-weekly (OW) placebo (Semaglutide) administered subcutaneously (s.c., under the skin).
Drug: Placebo (Semaglutide)
Placebo (Semaglutide) given subcutaneously (sc, under the skin) once weekly. Dose gradually increased over 8 weeks from 0.25 to 1.0 mg. The study will last for about 1 year.




Primary Outcome Measures :
  1. Change in kidney oxygenation (cortex), BOLD (blood oxygenation-level dependent) MRI ( magnetic resonance imaging ) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio

  2. Change in kidney oxygenation (medulla), BOLD MRI(R2) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio

  3. Change in global kidney perfusion (MRI) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio

  4. Change in kidney inflammation (cortex), T1 mapping (MRI) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio

  5. Change in kidney inflammation (medulla), T1 mapping (MRI) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio


Secondary Outcome Measures :
  1. Change in gene expression assessed by single nucleus RNA sequencing (kidney biopsy) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    log2 fold-change

  2. Change in glomerular basement membrane width (kidney biopsy) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    nm

  3. Change in ADC (apparent diffusion coefficient) (cortex) (MRI) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio

  4. Change in ADC (medulla) (MRI) [ Time Frame: From baseline (week 0) to end of treatment (week 52 ]
    ratio

  5. Change in mean RARI (renal artery resistive index ) (MRI) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio

  6. Change in mean arterial flow (MRI) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    ratio

  7. Change in natriuresis (urinary sodium excretion) (urinalysis) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    mmol/l

  8. Change in albumin excretion rate (urinalysis) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    mg/24 hours

  9. Change in kidney function (creatinine clearance) (urinalysis [ Time Frame: From baseline (week 0) to end of treatment (week 52 ]
    ml/min/1.73 m^2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female.
  • Age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening.
  • HbA1c (glycated haemoglobin) below or equal to 9.0 percent (below or equal to 75 mmol/mol).
  • Depending on biopsy/non-biopsy population:

    1. For subjects in the non-biopsy population: Serum creatinine-based eGFR greater than or equal to 30 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).
    2. For subjects in the biopsy sub-population: Serum creatinine-based eGFR greater than or equal to 40 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).
  • UACR ( Urinary albumin-to-creatinine ratio ) greater than or equal to 20 and below 5000 mg/g.
  • Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)) unless such treatment is contraindicated or not tolerated.Treatment dose must be stable for at least 28 days prior to screening.

Exclusion Criteria:

  • Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA) within 30 days prior to screening.
  • A prior solid organ transplant or awaiting solid organ transplant.
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
  • Presence or history of malignant neoplasms (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening.
  • Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and Visit 2. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Treatment with systemic anti-inflammatory or immunosuppressant drugs within 90 days prior to screening. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed.
  • Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared MR compatible.
  • Combination use of an ACE (angiotensin-converting enzyme) inhibitor and an ARB (angiotensin II receptor blockers).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865770


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, California
Novo Nordisk Investigational Site Suspended
Los Angeles, California, United States, 90022
Novo Nordisk Investigational Site Recruiting
San Dimas, California, United States, 91773
United States, Colorado
Novo Nordisk Investigational Site Recruiting
Aurora, Colorado, United States, 80045
United States, Missouri
Novo Nordisk Investigational Site Recruiting
Kansas City, Missouri, United States, 64111
United States, Texas
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78215
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78233
United States, Washington
Novo Nordisk Investigational Site Recruiting
Spokane, Washington, United States, 99204
Canada, Ontario
Novo Nordisk Investigational Site Not yet recruiting
Toronto, Ontario, Canada, M5G 2N2
France
Novo Nordisk Investigational Site Not yet recruiting
AMIENS cedex 1, France, 80054
Novo Nordisk Investigational Site Recruiting
Bois-Guillaume, France, 76230
Novo Nordisk Investigational Site Not yet recruiting
Grenoble - Cédex 09, France, 38043
Novo Nordisk Investigational Site Not yet recruiting
Reims, France, 51092
Novo Nordisk Investigational Site Not yet recruiting
Toulouse, France, 31059
Italy
Novo Nordisk Investigational Site Recruiting
Bergamo, Italy, 24127
Novo Nordisk Investigational Site Not yet recruiting
Milano, Italy, 20132
Novo Nordisk Investigational Site Not yet recruiting
Roma, Italy, 00189
Poland
Novo Nordisk Investigational Site Recruiting
Radom, Poland, 26-600
Novo Nordisk Investigational Site Suspended
Szczecin, Poland, 70-111
Novo Nordisk Investigational Site Recruiting
Zabrze, Poland, 41-800
South Africa
Novo Nordisk Investigational Site Recruiting
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site Recruiting
Cape Town, Western Cape, South Africa, 7925
Spain
Novo Nordisk Investigational Site Recruiting
Barcelona, Spain, 08035
Novo Nordisk Investigational Site Recruiting
Hospitalet de Llobregat, Spain, 08907
Novo Nordisk Investigational Site Recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (Dept.2834) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04865770    
Other Study ID Numbers: NN9535-4662
U1111-1248-7912 ( Other Identifier: World Health Organization (WHO) )
2020-000828-19 ( EudraCT Number )
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency