Diabetic Nephropathy
Conditions
Brief summary
The investigators designed a randomized parallel controlled clinical study, selected 98 cases of diabetic nephropathy patients with urinary protein \> 1g, randomly assigned into the Kunxian capsule + irbesartan group or irbesartan group, 48 weeks of treatment and follow-up, reduced levels of urinary protein and effective relief time, remission rate as the main end point, estimated glomerular filtration rate (eGFR) drop rate slope for secondary end points, safety events were also collected. To evaluate the efficacy and safety of Kunxian capsule combined with irbesartan in treatment of diabetic nephropathy compared with irbesartan alone.
Interventions
DRUGKunxian capsule
Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Conformed to the diagnostic criteria of diabetic nephropathy * No gender limitation, age 18-85 years old, no fertility requirement temporarily * eGFR: \>30ml/min/1.73m2（CKD-EPI） * Urine protein \>1 g/day * No glucocorticoids or/and immunosuppressive therapy was received within 3 months * Patients volunteered to participate in this study and signed the informed consent
Exclusion criteria
* Combined with diabetic acute complications or acute kidney injury (AKI) * Combined with other autoimmune diseases * Primary and other secondary renal diseases * Patients with hypotension (BP \< 90/60mmHg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (ARB) drugs * There are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules * There are fertility requirements or pregnant, lactation patients * Combined with malignant tumor, hepatitis, tuberculosis, HIV, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (COPD) and other serious systemic diseases * Kidney transplant or dialysis has been performed * Clinicians deem it inappropriate, or patients are unwilling to sign informed consent, have poor compliance, have a history of mental illness, or cannot complete follow-up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changed levels of urinary protein, gram | 48 weeks |
| Urinary protein remission rate, % | 48 weeks |
| The effective remission time of urinary protein, day | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Urinary albumin/creatinine ratio | 48 weeks |
| 24-hour urinary protein quantity, gram | 48 weeks |
| eGFR decline rate slope | 48 weeks |
| Number of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, % | 48 weeks |
| Time of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, days | 48 weeks |
Other
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by gastrointestinal reactions, % | 48 weeks |
| Number of participants with treatment-related adverse events as assessed by infection, % | 48 weeks |
| Number of participants with treatment-related adverse events as assessed by skin damage, % | 48 weeks |
| Number of participants with treatment-related adverse events as assessed by reproductive toxicity (menorrhea or amenorrhea or infertility), % | 48 weeks |
| Number of participants with treatment-related adverse events as assessed by liver damage, % | 48 weeks |
| Number of participants with treatment-related adverse events as assessed by bone marrow suppression, % | 48 weeks |
Countries
China
Outcome results
None listed