Clinical Study

Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial

Table 2

Exclusion criteria.

1Type 1 or secondary DM
2Allergy to TwHF
3Using any immunosuppressive agents
4No reliable contraceptive is being used
5Impaired liver function: ALT or AST the upper limit of normal
6
7Severe and refractory hypertension ()
8 month prior to the study
9Increase in serum creatinine during the study of ≥50% compared with baseline, inability to control severe hyperkalemia () during past, or contraindications for ARB use (e.g., bilateral renal artery stenosis)
10Serious cardiac or cerebrovascular event (heart failure, angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.) < 6 months prior to the study
11Risk factor for poor compliance such as nonresident or without health insurance (at the investigators’ discretion)
12Participation in other clinical drug trials < 6 months prior to the study
13Any medical practitioners deem that the trial is not suitable for the participant, for reasons such as cancer.

DM: diabetes mellitus; TwHF: Tripterygium wilfordii Hook F; ALT: alanine aminotransferase; AST: aspartate aminotransferase.