Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial
Table 2
Exclusion criteria.
1
Type 1 or secondary DM
2
Allergy to TwHF
3
Using any immunosuppressive agents
4
No reliable contraceptive is being used
5
Impaired liver function: ALT or AST the upper limit of normal
6
7
Severe and refractory hypertension ()
8
month prior to the study
9
Increase 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)
10
Serious cardiac or cerebrovascular event (heart failure, angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.) < 6 months prior to the study
11
Risk factor for poor compliance such as nonresident or without health insurance (at the investigators’ discretion)
12
Participation in other clinical drug trials < 6 months prior to the study
13
Any medical practitioners deem that the trial is not suitable for the participant, for reasons such as cancer.