Dapagliflozin in Non-diabetic Stage IV CKD (NCT04794517) | Clinical Trial Compass
CompletedPhase 2
Dapagliflozin in Non-diabetic Stage IV CKD
Italy32 participantsStarted 2021-11-08
Plain-language summary
This is a phase 2b, prospective, randomized, cross-over, double-blind, placebo-controlled trial primarily aimed at assessing whether the SGLT2 inhibitor dapagliflozin ameliorates hyperfiltration and reduces proteinuria as compared to placebo in patients with non-diabetic CKD, with particular focus on those at highest risk of progression to end stage kidney disease (ESKD) because of severe renal insufficiency (Stage IV CKD) and proteinuria (\>0.5 g/24 hours). The study will also evaluate renal and systemic mechanisms mediating treatment effects on GFR and will explore biochemical factors possibly mediating these effects.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures
✓. Male or female more than 18 year old
✓. Non-diabetic Stage-IV CKD
✓. Fasting blood glucose ≤ 125 mg (≤ 6.9 mmol/l) and HbA1C ≤6.4% (≤ 47 mmol/mol)58 without treatment with oral blood glucose lowering medications and/or insulin
✓. Two-hour plasma glucose \<200 mg/dl during 75-g oral glucose tolerance test (OGTT)58
✓. Persistent proteinuria (24-hour urinary protein excretion ≥ 0.5 grams in at least two consecutive evaluations \>1 week apart) despite RAS inhibitor therapy with ACE inhibitors and/or ARBs (or without RAS inhibitors in patients with specific contraindications to these medications)
✓. eGFR 15 to 30 ml/min/1.73 m2 by CKD-Epi equation
✓. Blood pressure \<150/90 mmHg without changes in blood pressure lowering medications over the last four weeks before the randomization
Exclusion criteria
✕
What they're measuring
1
Glomerular Filtration rate (GFR)
Timeframe: Changes from baseline and day 1, 8, 42,84, 92,126 and 140.
2
24-hour urinary protein excretion
Timeframe: Changes from start (day 0, day 84) and end (day 42, day 126) of each Treatment Period with dapagliflozin or placebo
Trial details
NCT IDNCT04794517
SponsorMario Negri Institute for Pharmacological Research
. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
✕. Participation in another clinical study with an investigational product during the last month
✕. Ischemic kidney disease (because of possible excess risk of acute kidney injury upon SGLT2-inhibitor associated reduction in sodium pool and kidney perfusion pressure)
✕. Rapidly progressive kidney disease (e GFR reduction ≥ 30% over the last three months) and expected risk of progression to end stage kidney failure and need of renal replacement therapy by dialysis or transplantation during the study period.
✕. Active systemic autoimmune diseases;
✕. Concomitant treatment with steroids or any other immunosuppressive agent
✕. Hypersensitivity to the active principle (dapagliflozin) or any of the excipients (e.g. lactose);
✕. Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months