chronic kidney disease

Chronic kidney disease (CKD) and end-stage renal disease trials have been revitalized by SGLT2 inhibitors, which reduce CKD progression in both diabetic and non-diabetic patients through hemodynamic and anti-inflammatory mechanisms beyond glucose lowering. Targeting residual risk after SGLT2 and RAAS inhibition is the current frontier, with mineralocorticoid receptor antagonists (finerenone) already approved.

Active trials evaluate sparsentan (dual endothelin-angiotensin antagonist) in IgAN, iptacopan for complement-mediated nephropathy, bardoxolone for Alport syndrome, and dicarba-based gene therapy for FSGS. Urine biomarkers (UACR, NGAL) and eGFR slope are standard endpoints, with surrogate-to-hard endpoint validation ongoing.

Disease Burden & Epidemiology

Chronic kidney disease (CKD) affects approximately 850 million people worldwide — nearly 10% of the global adult population — making it more prevalent than diabetes or chronic obstructive pulmonary disease. In the United States, the CDC estimates that 37 million American adults (15%) have CKD, of whom 9 in 10 are unaware of their diagnosis. CKD is defined by reduced kidney function (eGFR <60 mL/min/1.73m²) or evidence of kidney damage (primarily elevated urinary albumin) persisting for more than 3 months. Diabetes is the leading cause of CKD, responsible for approximately 40% of new end-stage renal disease (ESRD) cases; hypertension is the second most common cause. Globally, approximately 2.5 million people require kidney replacement therapy (dialysis or transplantation), but the true need is estimated at 5–10 times higher in low-income countries where access is limited. ESRD carries an annual mortality rate of 20–25% — substantially higher than many cancers — primarily driven by cardiovascular disease. The economic burden is staggering: Medicare spending for CKD and ESRD patients exceeded $150 billion in 2020 in the United States alone, representing 24% of all Medicare expenditure.

Key Research Trends & Landmark Studies

The CREDENCE trial established canagliflozin (SGLT2 inhibitor) as effective for kidney protection in diabetic CKD, reducing the composite of ESRD, doubling of serum creatinine, and renal or cardiovascular death by 30% β€” leading to FDA approval and transformation of CKD management guidelines. The DAPA-CKD trial extended dapagliflozin's benefit to both diabetic and non-diabetic CKD (the first CKD trial to do so), and the EMPA-KIDNEY trial further confirmed empagliflozin's renal protection across a broad CKD population regardless of diabetic status. The FIDELITY analysis (pooled FIDELIO-DKD and FIGARO-DKD) established finerenone (mineralocorticoid receptor antagonist) as an additive therapy on top of RAAS blockade and SGLT2 inhibitors. For IgA nephropathy specifically, the PROTECT trial for sparsentan, NEFIGARD for nefecon (targeted-release budesonide), and the iptacopan (complement factor B inhibitor) programs have produced positive Phase 3 results, with sparsentan and nefecon receiving FDA approval. The ATLAS trial for bardoxolone in CKD due to Alport syndrome is ongoing.

Patient Guide: How to Find & Join a Trial

Adults with CKD at any stage (G1–G5) may qualify for clinical trials, though eligibility varies substantially by eGFR range and underlying cause of kidney disease. Before approaching trial teams, know your most recent eGFR (estimated glomerular filtration rate, calculated from serum creatinine) and UACR (urine albumin-to-creatinine ratio) — these two values are the primary determinants of CKD stage and trial eligibility. The cause of your CKD (diabetic nephropathy, IgA nephropathy, focal segmental glomerulosclerosis, polycystic kidney disease, hypertensive nephrosclerosis, etc.) is equally critical, as many trials are disease-specific. Nephrology departments at academic medical centers and transplant programs offer the broadest access to CKD trials. For patients with rare glomerular diseases (IgAN, FSGS, membranous nephropathy), specialty glomerulonephritis clinics at academic centers are the primary enrollment sites. The American Kidney Fund (kidneyfund.org) and NKF (kidney.org) provide patient-facing clinical trial support resources.

Frequently Asked Questions — chronic kidney disease Clinical Trials

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