Ongoing and planned trials of combination therapy and recent trials with varying use of background evidence-based kidney therapies.
| Trial . | Number of participants . | Population . | Intervention and control . | Primary outcome . | Participants receiving RAS blockade (%) . | Participants receiving SGLT2i (%) . | Status . |
|---|---|---|---|---|---|---|---|
| CKD progression trials | |||||||
| FLOW | 3534 | T2D and CKD | Semaglutide vs. placebo | ≥50% decline in eGFR, kidney failure or death due to kidney failure or cardiovascular disease | 95.3 | 15.5 | Completed and reported in May 2024 |
| FIND-CKD | 1598 | Non-diabetic CKD | Finerenone vs. placebo | Total eGFR slope from baseline to 32 months | 99.8 | 16.9 | Estimated completion in 2026 |
| ARTIC | ∼2500 | CKD | Dapagliflozin/baxdrostat vs. dapagliflozin | Change in eGFR from baseline to 24 months + 6 weeks off-treatment | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| EASi-KIDNEY | ∼11 000 | CKD | BI 690517 (aldosterone synthase inhibitor)/empagliflozin vs. empagliflozin | CKD progression, heart failure hospitalization or cardiovascular death | ∼100 | 100 | Recruitment to commence in 2024 |
| ZENITH-HP | ∼1500 | CKD | Zibotentan/dapagliflozin vs. dapagliflozin | Change in eGFR from baseline to 24 months | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| Heart failure and CKD | |||||||
| BALANCED-HF | ∼4800 | Heart failure and CKD | Balcinrenone (MR modulator)/dapagliflozin vs. dapagliflozin | Cardiovascular death or worsening heart failure event | TBD | 100 | Currently recruiting |
| Glomerular diseases | |||||||
| ALIGN | 320 + 64 in dedicated SGLT2i stratum | IgA nephropathy | Atrasentan vs. placebo | Change in proteinuria (UPCR) at 36 weeks Confirmatory endpoint: change in eGFR up to week 136 (4 weeks off-treatment) | ∼100 | 16.6 (dedicated SGLT2i stratum) | Estimated completion 2026 Interim analysis complete and reported |
| ASSIST | 52 | IgA nephropathy | Atrasentan (cross over trial) | Change in proteinuria (UPCR) at 12 weeks | ∼100 | 100 | Estimated completion October 2025 |
| Type 1 diabetes | |||||||
| ASPIRE | 36 | T1D | Ambrisentan and sotagliflozin alone then in combination | Change in albuminuria (UACR) | ∼100 | 100 | Not yet recruiting |
| Trial . | Number of participants . | Population . | Intervention and control . | Primary outcome . | Participants receiving RAS blockade (%) . | Participants receiving SGLT2i (%) . | Status . |
|---|---|---|---|---|---|---|---|
| CKD progression trials | |||||||
| FLOW | 3534 | T2D and CKD | Semaglutide vs. placebo | ≥50% decline in eGFR, kidney failure or death due to kidney failure or cardiovascular disease | 95.3 | 15.5 | Completed and reported in May 2024 |
| FIND-CKD | 1598 | Non-diabetic CKD | Finerenone vs. placebo | Total eGFR slope from baseline to 32 months | 99.8 | 16.9 | Estimated completion in 2026 |
| ARTIC | ∼2500 | CKD | Dapagliflozin/baxdrostat vs. dapagliflozin | Change in eGFR from baseline to 24 months + 6 weeks off-treatment | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| EASi-KIDNEY | ∼11 000 | CKD | BI 690517 (aldosterone synthase inhibitor)/empagliflozin vs. empagliflozin | CKD progression, heart failure hospitalization or cardiovascular death | ∼100 | 100 | Recruitment to commence in 2024 |
| ZENITH-HP | ∼1500 | CKD | Zibotentan/dapagliflozin vs. dapagliflozin | Change in eGFR from baseline to 24 months | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| Heart failure and CKD | |||||||
| BALANCED-HF | ∼4800 | Heart failure and CKD | Balcinrenone (MR modulator)/dapagliflozin vs. dapagliflozin | Cardiovascular death or worsening heart failure event | TBD | 100 | Currently recruiting |
| Glomerular diseases | |||||||
| ALIGN | 320 + 64 in dedicated SGLT2i stratum | IgA nephropathy | Atrasentan vs. placebo | Change in proteinuria (UPCR) at 36 weeks Confirmatory endpoint: change in eGFR up to week 136 (4 weeks off-treatment) | ∼100 | 16.6 (dedicated SGLT2i stratum) | Estimated completion 2026 Interim analysis complete and reported |
| ASSIST | 52 | IgA nephropathy | Atrasentan (cross over trial) | Change in proteinuria (UPCR) at 12 weeks | ∼100 | 100 | Estimated completion October 2025 |
| Type 1 diabetes | |||||||
| ASPIRE | 36 | T1D | Ambrisentan and sotagliflozin alone then in combination | Change in albuminuria (UACR) | ∼100 | 100 | Not yet recruiting |
T2D: type 2 diabetes; MR; mineralocorticoid receptor; UPCR: urinary protein: creatinine ratio; UACR: urinary albumin: creatinine ratio; T1D: type 1 diabetes.
Ongoing and planned trials of combination therapy and recent trials with varying use of background evidence-based kidney therapies.
| Trial . | Number of participants . | Population . | Intervention and control . | Primary outcome . | Participants receiving RAS blockade (%) . | Participants receiving SGLT2i (%) . | Status . |
|---|---|---|---|---|---|---|---|
| CKD progression trials | |||||||
| FLOW | 3534 | T2D and CKD | Semaglutide vs. placebo | ≥50% decline in eGFR, kidney failure or death due to kidney failure or cardiovascular disease | 95.3 | 15.5 | Completed and reported in May 2024 |
| FIND-CKD | 1598 | Non-diabetic CKD | Finerenone vs. placebo | Total eGFR slope from baseline to 32 months | 99.8 | 16.9 | Estimated completion in 2026 |
| ARTIC | ∼2500 | CKD | Dapagliflozin/baxdrostat vs. dapagliflozin | Change in eGFR from baseline to 24 months + 6 weeks off-treatment | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| EASi-KIDNEY | ∼11 000 | CKD | BI 690517 (aldosterone synthase inhibitor)/empagliflozin vs. empagliflozin | CKD progression, heart failure hospitalization or cardiovascular death | ∼100 | 100 | Recruitment to commence in 2024 |
| ZENITH-HP | ∼1500 | CKD | Zibotentan/dapagliflozin vs. dapagliflozin | Change in eGFR from baseline to 24 months | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| Heart failure and CKD | |||||||
| BALANCED-HF | ∼4800 | Heart failure and CKD | Balcinrenone (MR modulator)/dapagliflozin vs. dapagliflozin | Cardiovascular death or worsening heart failure event | TBD | 100 | Currently recruiting |
| Glomerular diseases | |||||||
| ALIGN | 320 + 64 in dedicated SGLT2i stratum | IgA nephropathy | Atrasentan vs. placebo | Change in proteinuria (UPCR) at 36 weeks Confirmatory endpoint: change in eGFR up to week 136 (4 weeks off-treatment) | ∼100 | 16.6 (dedicated SGLT2i stratum) | Estimated completion 2026 Interim analysis complete and reported |
| ASSIST | 52 | IgA nephropathy | Atrasentan (cross over trial) | Change in proteinuria (UPCR) at 12 weeks | ∼100 | 100 | Estimated completion October 2025 |
| Type 1 diabetes | |||||||
| ASPIRE | 36 | T1D | Ambrisentan and sotagliflozin alone then in combination | Change in albuminuria (UACR) | ∼100 | 100 | Not yet recruiting |
| Trial . | Number of participants . | Population . | Intervention and control . | Primary outcome . | Participants receiving RAS blockade (%) . | Participants receiving SGLT2i (%) . | Status . |
|---|---|---|---|---|---|---|---|
| CKD progression trials | |||||||
| FLOW | 3534 | T2D and CKD | Semaglutide vs. placebo | ≥50% decline in eGFR, kidney failure or death due to kidney failure or cardiovascular disease | 95.3 | 15.5 | Completed and reported in May 2024 |
| FIND-CKD | 1598 | Non-diabetic CKD | Finerenone vs. placebo | Total eGFR slope from baseline to 32 months | 99.8 | 16.9 | Estimated completion in 2026 |
| ARTIC | ∼2500 | CKD | Dapagliflozin/baxdrostat vs. dapagliflozin | Change in eGFR from baseline to 24 months + 6 weeks off-treatment | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| EASi-KIDNEY | ∼11 000 | CKD | BI 690517 (aldosterone synthase inhibitor)/empagliflozin vs. empagliflozin | CKD progression, heart failure hospitalization or cardiovascular death | ∼100 | 100 | Recruitment to commence in 2024 |
| ZENITH-HP | ∼1500 | CKD | Zibotentan/dapagliflozin vs. dapagliflozin | Change in eGFR from baseline to 24 months | ∼100 | 100 | Currently recruiting; estimated completion in 2027 |
| Heart failure and CKD | |||||||
| BALANCED-HF | ∼4800 | Heart failure and CKD | Balcinrenone (MR modulator)/dapagliflozin vs. dapagliflozin | Cardiovascular death or worsening heart failure event | TBD | 100 | Currently recruiting |
| Glomerular diseases | |||||||
| ALIGN | 320 + 64 in dedicated SGLT2i stratum | IgA nephropathy | Atrasentan vs. placebo | Change in proteinuria (UPCR) at 36 weeks Confirmatory endpoint: change in eGFR up to week 136 (4 weeks off-treatment) | ∼100 | 16.6 (dedicated SGLT2i stratum) | Estimated completion 2026 Interim analysis complete and reported |
| ASSIST | 52 | IgA nephropathy | Atrasentan (cross over trial) | Change in proteinuria (UPCR) at 12 weeks | ∼100 | 100 | Estimated completion October 2025 |
| Type 1 diabetes | |||||||
| ASPIRE | 36 | T1D | Ambrisentan and sotagliflozin alone then in combination | Change in albuminuria (UACR) | ∼100 | 100 | Not yet recruiting |
T2D: type 2 diabetes; MR; mineralocorticoid receptor; UPCR: urinary protein: creatinine ratio; UACR: urinary albumin: creatinine ratio; T1D: type 1 diabetes.
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