Treating mild kidney failure over 24 weeks in people with or without type 2 diabetes or high blood pressure

Phase 1

• Conditions: Microalbuminuria; MedDRA version: 20.1Level: PTClassification code 10027525Term: MicroalbuminuriaSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2021-004073-31-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Age 45 to 80 years
• Persistent urinary albumin:creatinine ratio (UACR) = 2.5 mg/mmol (~25 mg/g)
• Willing to sign informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

• Diagnosis of type 1 diabetes mellitus
• eGFR < 25 ml/min/1.73m2
• UACR > 3500 mg/g
• Concurrent treatment with SGLT2 inhibitor
• Receiving immunosuppressive therapy within 6 months prior to enrolment
• History of diabetic ketoacidosis
• Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
• Initiation or changes in the dose of interventions in the renin-angiotensin-aldosterone-system, diuretics, GLP-1 receptor agonists within 6 weeks of screening will not be allowed.
• 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:
oHistory of active inflammatory bowel disease within the last six months;
oMajor gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
oGastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
oPancreatic injury or pancreatitis within the last six months;
oEvidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
oEvidence of urinary obstruction or difficulty in voiding at screening
• History of severe hypersensitivity or contraindications to dapagliflozin
• Subjects who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data
• Participation in any clinical intervention study within 3 months prior to initial dosing.
• 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.
• History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
• 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.
• Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria. ;Secondary Objective: To assess effects of dapagliflozin compared to placebo on the following parameters: <br>o Systolic and diastolic blood pressure<br>o Body weight<br>o Hba1c<br>o eGFR<br>o Proportion of patients with =30%, 40%, 50% reduction in UACR from baseline at week 24. <br><br>To assess the safety of dapagliflozin;Primary end point(s): Change in first morning UACR from baseline;Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes from baseline in:<br>•Systolic / diastolic blood pressure<br>•Body weight<br>•Hba1c<br>•eGFR<br>•Number of patients with =30%, 40%, 50% reduction in UACR from baseline at week 24<br>;Timepoint(s) of evaluation of this end point: 24 weeks