Last updated 28 days ago
A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
465 patients around the world
Available in Brazil, Argentina
Novo Nordisk A/S
10Research sites
465Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Female of non-childbearing potential, or male.For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it throughout the study, or male.Age 18 years or above at the time of signing the informed consent.Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening, or not diagnosed with type 2 diabetes mellitus.HbA1c of 6.5 percentage -10.5 percentage (48 - 91 millimoles per mole) (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than 6.5 percentage [<48 mmol/mol] if not diagnosed with type 2 diabetes mellitus.BMI greater than or equal to 27.0 kilogram per square metre at screening.Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to 15 and less than 90 mL/min/1.73 m^2.Albuminuria defined by Urine Albumin-to-Creatinine Ratio greater than or equal to 100 and less than 5000 milligram per gram.Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective non-systemic contraception with low user-dependency.Lupus nephritis or antineutrophil cytoplasmic antibody-associated vasculitis.Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to enrolment.Use of any glucagon-like peptide-1 RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening.Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.Only applicable for participants with type 2 diabetes: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Centro Médico Cimel Chahin Chahin S.A.
Instituto de Cardiología Juana Francisca Cabral - Corrientes
Centro de Diabetes Curitiba - Curitiba, Parana
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
Quanta Diagnóstico por Imagem
Fundação Pró-Renal
SponsorNovo Nordisk A/S
Conditions
Chronic kidney disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06717698
