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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04865770
Other study ID # NN9535-4662
Secondary ID U1111-1248-79122
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 28, 2021
Est. completion date November 18, 2024

Study information

Verified date March 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date November 18, 2024
Est. primary completion date October 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

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 (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.

Locations

Country Name City State
Canada UHN-Toronto General Hospital Toronto Ontario
Denmark Nefrologisk Klinik P 2132 Copenhagen
Denmark Steno Diabetes Center Copenhagen Herlev
France Centre Hospitalier Universitaire Amiens Picardie-Site Sud AMIENS cedex 1
France Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume Bois-Guillaume
France Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2 Grenoble - Cédex 09
France Centre Hospitalier Universitaire Reims-Hopital Maison Blanche Reims
France Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Toulouse
Italy Azienda Ospedaliera Papa Giovanni XXIII Bergamo
Italy Istituto Scientifico San Raffaele Milano MI
Italy Azienda Ospedaliera di Padova Clin.Med.3 Padova
Italy Azienda Ospedaliero - Universitaria Sant'Andrea Roma
Poland In-Vivo Sp. z o.o. Bydgoszcz
Poland Centrum Medyczne "Diabetika" Radom
Poland SPSK nr 2 PUM, Kl. Nefrologii, Transplantologii i Ch. Wewn. Szczecin
Poland Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny Warszawa
Poland Prywatny Gabinet Janusz Gumprecht Zabrze
South Africa Prof Rayner Cape Town Western Cape
South Africa Maxwell Centre Durban KwaZulu-Natal
South Africa Precise Clinical Solutions (Pty) Ltd Durban KwaZulu-Natal
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital de Bellvitge Hospitalet de Llobregat
Spain Hospital Clínico Universitario de Valencia Valencia
United States UC Anschutz Medical Campus Aurora Colorado
United States Prolato Clinical Research Center Houston Texas
United States Clinical Research Consultants, LLC Kansas City Missouri
United States Academic Medical Research Institute Los Angeles California
United States Advent Health-Res Inst Orlando Florida
United States NE Clin Res of San Antonio San Antonio Texas
United States N America Res Inst - San Dimas San Dimas California
United States Univ of Washington Med Ctr Seattle Washington
United States Providence Medical Research Center Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Italy,  Poland,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in kidney oxygenation (cortex), BOLD (blood oxygenation-level dependent) MRI ( magnetic resonance imaging ) ratio From baseline (week 0) to end of treatment (week 52)
Primary Change in kidney oxygenation (medulla), BOLD MRI(R2) ratio From baseline (week 0) to end of treatment (week 52)
Primary Change in global kidney perfusion (MRI) ratio From baseline (week 0) to end of treatment (week 52)
Primary Change in kidney inflammation (cortex), T1 mapping (MRI) ratio From baseline (week 0) to end of treatment (week 52)
Primary Change in kidney inflammation (medulla), T1 mapping (MRI) ratio From baseline (week 0) to end of treatment (week 52)
Secondary Change in gene expression assessed by single nucleus RNA sequencing (kidney biopsy) log2 fold-change From baseline (week 0) to end of treatment (week 52)
Secondary Change in glomerular basement membrane width (kidney biopsy) nm From baseline (week 0) to end of treatment (week 52)
Secondary Change in ADC (apparent diffusion coefficient) (cortex) (MRI) ratio From baseline (week 0) to end of treatment (week 52)
Secondary Change in ADC (medulla) (MRI) ratio From baseline (week 0) to end of treatment (week 52
Secondary Change in mean RARI (renal artery resistive index ) (MRI) ratio From baseline (week 0) to end of treatment (week 52)
Secondary Change in mean arterial flow (MRI) ratio From baseline (week 0) to end of treatment (week 52)
Secondary Change in natriuresis (urinary sodium excretion) (urinalysis) mmol/l From baseline (week 0) to end of treatment (week 52)
Secondary Change in albumin excretion rate (urinalysis) mg/24 hours From baseline (week 0) to end of treatment (week 52)
Secondary Change in kidney function (creatinine clearance) (urinalysis ml/min/1.73 m^2 From baseline (week 0) to end of treatment (week 52
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