Table 5.
Clinical trials of antifibrotic drug in CKD
| Drug | Target | Disease | Phase | Outcome | ClinicalTrials.gov Identifier |
|---|---|---|---|---|---|
| FG-3019 | CTGF | FSGS | 1 | Terminated | NCT00782561 |
| Microalbuminuric DKD | 1 |
Treatment was well tolerated; Decrease in albuminuria |
NCT00102297 | ||
| DKD with urine ACR > 200 mg/g | 1 | Unknown | NCT00754143 | ||
| Type 2 diabetes and DKD with urine ACR > 200–3000 mg/g | 2 | Terminated early for business purposes | NCT00913393 | ||
| RG-012 | miR-21 | Alport syndrome | 1 | Unknown | NCT03373786 |
| Bardoxolone methyl | Nrf2 | CKD at risk of rapid progression | 2 | Increase in the eGFR | NCT04702997 |
| Patients with advanced CKD and type 2 diabetes | 2 | Increase in the eGFR | NCT00811889 (BEAM study) | ||
| CKD patients with type 2 diabetes | 2 | Increase in measured GFR | NCT02316821 (TSUBAKI study) | ||
| IgAN, CKD associated with type 1 diabetes, FSGS, ADPKD | 2 | Increase in the eGFR | NCT03366337 | ||
| Patients with type 2 diabetes and stage 4 CKD | 3 |
No reduction in the risk of ESKD or death from cardiovascular causes; Increased rate of cardiovascular events |
NCT01351675 (BEACON study) | ||
| Alport syndrome | 2/3 | Preservation in eGFR | NCT03019185 (CARDINAL study) | ||
| Pirfenidone | TGF-β | FSGS | 2 |
Decreased GFR loss; No change in proteinuria |
NCT00001959 |
| DKD | 1/2 | GFR increased in the pirfenidone 1200-mg/d group | NCT00063583 | ||
| DKD | 3 | Unknown | NCT02689778 | ||
| GCS-100 | Galectin-3 | CKD | 1 | Unknown | NCT01717248 |
| CKD | 2 | Unknown | NCT01843790, NCT02155673 | ||
| DKD | 2 | Unknown | NCT02312050 | ||
| Apabetalone | BET | Fabry Disease | 1/2 | Unknown | NCT03228940 |
| CKD subjects with a history of CVD | 2 |
Apabetalone was well tolerated; Favorable effects of apabetalone on ALP and eGFR |
Post-hoc analysis of NCT01423188 (SUSTAIN study) and NCT01067820 (ASSURE study) | ||
| Patients with CKD and type 2 diabetes | 3 | Apabetalone was associated with a reduced hazard for MACE and heart failure hospitalization | CKD subgroup analysis of NCT02586155 (BETonMACE study) |
ACR albumin-creatinine ratio, ADPKD autosomal dominant polycystic kidney disease, ALP alkaline phosphatase, BET bromodomain and extraterminal, CKD chronic kidney disease, CTGF connective tissue growth factor CVD cardiovascular disease, DKD diabetic kidney disease, eGFR estimated glomerular filtration rate, ESKD end-stage kidney disease, FSGS focal segmental glomerulosclerosis, IgAN IgA nephropathy, MACE major adverse cardiovascular event, TGF-β transforming growth factor beta