Safety and efficacy of Tripterygium wilfordii Hook F in diabetic kidney disease: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086105

Enrollment

Unknown

Registered

2024-06-25

Start date

2024-06-30

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DKD

Interventions

TASM:TwHF+ARB/ACEI+SGLT2i+TwHF

ASM:ARB/ACEI+SGLT2i+TwHF

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Signed written informed consent; (2) Age 18-80 years; (3) Patients with type 2 diabetes; (4) Patients with pathological diagnosis of diabetic nephropathy; (5) eGFR = 25ml/min/1.73m2 or UACR = 1000mg/g; (6) Serum potassium = 5.0mmol/l at the initial visit; (7) No other immunosuppressants were used within 3 months.

Exclusion criteria

Exclusion criteria: (1) Type 1 diabetes or other types of diabetes; (2) Those who are allergic to drug ingredients; (3) Other reasons for instability or rapid decline of renal function, such as acute kidney injury (previous events are not excluded); (4) Have diabetic acidosis and / or hyperosmolar hyperglycemia; (5) Recurrent genitourinary tract infections occurred within half a year; (6) Patients with severe heart, liver and kidney dysfunction; (7) Previous history of organ transplantation or chronic liver disease; (8) Non-menopausal women who are pregnant, breastfeeding, or still have pregnancy plans, or cannot accept the potential reproductive toxic side effects of T; (9) Patients with symptomatic hypotension and / or systolic blood pressure <90 mmHg, or low blood volume as judged by clinicians; (10) White blood cell count < 3.0 × 109 /L; (11) Being or recently using glucagon-like peptide-1 receptor agonists; (12) The expected life of the screening period is less than 2 years; (13) Patients with confirmed malignancies; (14) A history of drug or alcohol abuse; (15) Participated in other drug clinical studies 3 months before screening; (16) Those who have lost the ability to act autonomously; (17) The investigator considered it inappropriate to participate in the clinical study.

Design outcomes

Primary

Measure	Time frame
24-hour urinary protein excretion;	—

Secondary

Measure	Time frame
Urinary biochemistry (UACR);Liver and kidney function;Blood routine;Urinalysis;Complement;Glycosylated hemoglobin;Serum electrolytes;eGFR;	—

Countries

China

Contacts

Public ContactHe Lijie

Nephrology Department of Xijing Hospital

shaona@ldy.edu.rs+86 182 2908 4817

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026