Table 5 Clinical trials of antifibrotic drug in CKD

From: Kidney fibrosis: from mechanisms to therapeutic medicines

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)

  1. 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