Semaglutide for Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Urinary albumin to creatinine ratio ≥100 mg/g and ≤3500 mg/g"}
• {"criterion_text":"- eGFR ≥25 and ≤90 mL/min/1.73m2"}
• {"criterion_text":"- HbA1c ≥5.7% and <11%"}
• {"criterion_text":"- On a stable dose of an ACEi/ARB for at least 4 weeks if tolerated"}
• {"criterion_text":"- On a stable dose of a SGLT2 inhibitor for at least 4 weeks if tolerated"}
• {"criterion_text":"- Willing to sign an informed consent"}

Exclusion criteria

• {"criterion_text":"- Diagnosis of type 1 diabetes"}
• {"criterion_text":"- Active pregnancy or breastfeeding"}
• {"criterion_text":"- History of kidney or liver transplant"}
• {"criterion_text":"- History of chronic pancreatitis or idiopathic acute pancreatitis"}
• {"criterion_text":"- Active malignancy"}
• {"criterion_text":"- Suggestive evidence of adrenal insufficiency"}
• {"criterion_text":"- Heart Failure with reduced ejection fraction"}
• {"criterion_text":"- Use of any of the following medications: CYP3A4 inhibitors, potassium sparing medications, trimethoprim, trimethoprim/sulfamethoxazole, GLP-1 RAs, and potassium supplements."}
• {"criterion_text":"- Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma"}
• {"criterion_text":"- Personal history of non-familial medullary thyroid carcinoma"}
• {"criterion_text":"- History of severe hypersensitivity or contraindications to any MRA or GLP-1 RA"}
• {"criterion_text":"- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator’s assessment."}
• {"criterion_text":"- Uncontrolled arterial hypertension (mean sitting systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)"}
• {"criterion_text":"- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease within the 6 months; Major gastrointestinal tract surgery as determined by the physician; Pancreatitis within 6 months. GI ulcers and/or bleeding within 6 months; Evidence of urinary obstruction or difficulty in voiding at screening."}
• {"criterion_text":"- Participation in any clinical trial within 3 months prior to initial dosing."}
• {"criterion_text":"- Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing."}
• {"criterion_text":"- •\tVulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)"}
• {"criterion_text":"- History of noncompliance to medical regimens or unwillingness to comply with the study protocol."}
• {"criterion_text":"- Heart Failure with reduced ejection fraction and NYHA Class II to IV"}
• {"criterion_text":"- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study."}
• {"criterion_text":"- Women of childbearing potential (WOCBP): WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized; WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening."}
• {"criterion_text":"- Acute coronary syndrome event within 6 months"}
• {"criterion_text":"- Serum potassium > 5.0 mmol/L"}
• {"criterion_text":"- Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt"}

Primary endpoints

• {"endpoint_text":"- Endpoint parameter is the percentage change from baseline in UACR.","definition_or_measurement_approach":"Percentage change from baseline in urinary albumin-to-creatinine ratio (UACR)."}

Secondary endpoints

• {"endpoint_text":"- Percentage change from baseline in UACR.","definition_or_measurement_approach":"Percentage change from baseline in urinary albumin-to-creatinine ratio (UACR)."}
• {"endpoint_text":"- Number of missed urine collection in the remote (@home) setting","definition_or_measurement_approach":"Count of missed urine collections in the remote (at-home) setting."}

Spain

Earliest CTIS Part Ii Submission Date

03-04-2024

Latest Decision Or Authorization Date

21-08-2024

Processing Time Days

140

Number Of Sites

2

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

25-03-2024

Latest Decision Or Authorization Date

28-08-2024

Processing Time Days

156

Number Of Sites

2

Number Of Participants

10

Netherlands

Earliest CTIS Part Ii Submission Date

08-04-2024

Latest Decision Or Authorization Date

21-08-2024

Processing Time Days

135

Number Of Sites

2

Number Of Participants

10

Denmark

Earliest CTIS Part Ii Submission Date

29-03-2024

Latest Decision Or Authorization Date

22-08-2024

Processing Time Days

146

Number Of Sites

1

Number Of Participants

6

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Denmark","full_name":"GCP unit at University of Copenhagen","duties_or_roles":"sponsor duties code 1","organisation_type":"Educational Institution"}