Observational studyNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2026
Renal functional reserve predicts GFR response to empagliflozin in RENALIS and RACELINES clinical trials.
Observational study in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 4, Monocenter, Randomized, Double-blind, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Linagliptin Versus the Sulfonylurea (SU) Derivative Glimepiride on Renal Physiology and Biomarkers in Metformin-treated Patients With Type 2 Diabetes Mellitus (T2DM)
RACELINES: Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES
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8 authors.
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Abstract
backgroundGlomerular hyperfiltration is common in type 2 diabetes (T2D) and may reflect reduced nephron number and/or perturbed intrarenal hemodynamics. Renal functional reserve (RFR), the capacity to increase glomerular filtration rate (GFR) with physiological stimuli (e.g. a meal), may help reveal single-nephron hyperfiltration in patients with preserved baseline whole-kidney GFR. We hypothesized that reduced postprandial RFR predicts the acute hemodynamic GFR response in T2D to the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin, but not to the dipeptidyl-peptidase-4 inhibitor linagliptin or a sulfonylurea.
methodsThis analysis pooled data from two 8-week randomized, double-blind, parallel-group mechanistic trials, encompassing 71 T2D patients with preserved whole-kidney GFR [mean ± standard deviation age 65 ± 7 years, boby mass index 30.4 ± 3.9 kg/m2, glycated hemoglobin A1c 7.8 ± 1.0% (61.6 ± 11.0 mmol/mol), GFR 86.5 ± 17.6 mL/min/1.73 m2]. Patients received empagliflozin (10 mg; N = 20), linagliptin (5 mg; N = 27) or sulfonylurea (glimepiride 1 mg or gliclazide 30 mg; N = 24), in addition to metformin. Measured (m)GFR and effective renal plasma flow (ERPF) were determined by inulin/iohexol and para-aminohippurate clearance, respectively, based on timed urine sampling in fasting and post-protein-rich meal conditions. Intrarenal hemodynamics were calculated using Gomez equations; fractional sodium excretion (FENa) and systemic hemodynamics were evaluated.
resultsThe meal increased mGFR (+7.3 ± 1.7 mL/min/1.73 m2; P < .001) and ERPF (+44.3 ± 14.9 mL/min/1.73 m2; P = .005), with concomitant decrease in renal vascular resistance (RVR; -0.02 ± 0.01 mmHg/L/min; P < .001), driven by reduced afferent arteriolar resistance (-1068 ± 241dyne/s/cm5; P < .001) and lower FENa (-0.21 ± 0.05; P < .001). Postprandial mGFR changes did not correlate with baseline mGFR, but did correlate with postprandial RVR change (r: -0.57; P < .001). After 8 weeks, mGFR tended to decrease with sulfonylurea (P = .054) and decreased with empagliflozin (-9.1 ± 3.2 mL/min/1.73 m2; P = .016), but not with linagliptin. Baseline meal-induced mGFR changes correlated with 8-week treatment-induced mGFR changes with empagliflozin (r: 0.88; P < .001), but not with linagliptin or sulfonylurea.
conclusionBaseline postprandial RFR predicts GFR-dipping with empagliflozin after 8 weeks, but not with GFR changes following linagliptin or sulfonylurea. As initial GFR dipping is associated with long-term kidney benefit, RFR warrants evaluation as a potential additional tool to personalize SGLT2 inhibitor therapy.
trial registrationClinicalTrials.gov: NCT02106104 (RENALIS) and NCT03433248 (RACELINES).
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