Diabetic Kidney Disease
Conditions
Interventions
Integrated Chinese and Western Medicine Treatment Group:Combined use of Congrong Yishen Granules (2 g each time, twice daily) and Vitamin D2 Soft Capsules (initial treatment dose of 0.125 mg [5,000 IU
Conventional Western Medicine Treatment Group:Conventional Western Medicine-Based Basic Treatment
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Type 2 Diabetic Kidney Disease. 2. Patients diagnosed with the Syndrome of Kidney Qi Deficiency based on Traditional Chinese Medicine (TCM) syndrome differentiation. 3. Patients eligible for the trial must meet the following criteria based on tests at both the start and the end of the run-in period: eGFR = 45 ml/min-1/1.73m-2 (calculated using the CKD-EPI equation); and 30 = UACR = 3000 mg/g. 4. Patients with serum 25-hydroxyvitamin D [25(OH)D] < 30 ng/mL. 5. Patients with serum calcium levels within the normal reference range of the central laboratory. 6. Patients with 24-hour urinary calcium = 7.5 mmol. 7. Patients with PTH = 500 pg/ml. 8. Patients with blood pressure = 90/60 mmHg and = 160/100 mmHg. 9.Patients with glycated hemoglobin (HbA1c) = 9% at the start of the run-in period. 10. Patients with 24-hour urinary protein quantification = 3.5 g. 11. For patients already receiving medications affecting proteinuria (such as ACEIs/ARBs, SGLT2 inhibitors, or finerenone) prior to enrollment, treatment for Diabetic Kidney Disease must have been ongoing for at least 6 months before enrollment. 12. Patients who agree to discontinue vitamin D analogs (such as Calcitriol, Alfacalcidol, and Eldecalcitol) during the study period. 13. Patients aged between 18 and 75 years, inclusive, irrespective of gender. 14. Patients who voluntarily participate in this clinical trial, provide informed consent, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes mellitus or other specific types of diabetes. 2. Patients with acute diabetic complications within the last 3 months, or those with other primary or secondary renal impairments. 3. Patients whose eGFR at the end of the run-in period has decreased by = 25% compared to pre-run-in (screening) levels. 4. Patients with ALT or AST = 3 times the upper limit of normal (ULN), hemoglobin = 90 g/L, or serum potassium below the lower limit or above the upper limit of the normal reference range at baseline. 5. Patients with concurrent acute infectious diseases; active or chronic active hepatitis B; decompensated liver cirrhosis; active tuberculosis; heart failure; cardiovascular accidents; trauma; surgery; urinary tract obstruction; severe edema (e.g., pleural effusion, ascites, pericardial effusion); renal artery stenosis; renovascular hypertension; congenital renal anomalies; or status post nephrectomy. 6. Patients with allergic constitution or known allergy to any known component of the investigational drugs. 7. Patients with proteinuria due to other causes. 8. Patients who have used systemic corticosteroids or immunosuppressants within the last 3 months, currently require such therapy, or require renal replacement therapy. 9. Women of childbearing potential who are pregnant, breastfeeding, have a pregnancy intention, or have a positive pregnancy test (urine or serum HCG), and are unable to use effective contraception during the trial and for 3 months after the trial ends. Effective contraception includes sterilization, intrauterine device, oral contraceptives, or barrier methods as per local regulations. 10. Patients who have undergone major head, thoracic, or abdominal surgery within the last 4 weeks, or those with bleeding tendencies. 11. Patients with legally defined disabilities (blindness, deafness, mutism, intellectual disability, mental disorders, physical disabilities) or those unable to express their will appropriately. 12. Patients with severe cardiac, cerebral, hepatic, pulmonary, renal, or hematopoietic system diseases, or uncontrolled comorbid conditions, whom the investigator deems unsuitable for clinical trial participation. 13. Patients with a history of alcohol abuse, drug abuse, or addiction. 14. Patients who have participated in other drug or medical device clinical trials within the last 3 months. 15. Patients whom the investigator considers unable to have their efficacy evaluated or unlikely to complete the expected trial course.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| GFR;Efficacy on TCM syndrome overall and individual symptoms;25-Hydroxyvitamin D [25(OH)D];the erectile function domain score of the IIEF-5; | — |
Primary
| Measure | Time frame |
|---|---|
| Urine Albumin-to-Creatinine Ratio (UACR); | — |
Countries
China
Contacts
Public ContactBu Shi
China-Japan Friendship Hospital
Outcome results
None listed