Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD).
Main Question it Aims to Answer:
▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo?
Researchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline.
Participants will:
* Undergo screening tests to determine eligibility. * Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks. * Take the study medication twice daily for 12 weeks. * Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups. * Have their safety monitored through reporting of any health changes and routine lab tests.
Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
A urine albumin-to-creatinine ratio (UACR) >200 mg/g on at least two separate occasions before screening.
A clinical diagnosis of CKD (KDIGO stage G1 to G3b) for at least 3 months, and an estimated glomerular filtration rate (eGFR) between 30 and 120 ml/min/1.73 m² at screening (using the CKD-EPI creatinine-cystatin C formula).
Confirmed diagnosis of T2DM. If on medication for T2DM, the dose must have been stable for at least 3 months before enrollment. At screening, HbA1c must be ≤9%.
Exclusion Criteria Subjects who meet any of the following criteria are excluded from participation in the study. Exclusion criteria based on lab values refer to the most recent results obtained prior to randomization.
Congenital or hereditary kidney diseases, including polycystic kidney disease, autoimmune kidney diseases (e.g., glomerulonephritis), or congenital urinary tract malformations.
Currently receiving (or within the past 90 days) chronic or intermittent hemodialysis or peritoneal dialysis.
Clinically or histologically confirmed liver cirrhosis (Fibrosis Stage 4).
Parallel
HTD1801
Drug1000mg (as 4 capsules), twice a day for 12 weeks
placebo
Other intervention4 placebo capsules, twice a day for 12 weeks.
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline at Week 12
Proportion of subjects achieving a ≥30% reduction in UACR and a <30% decline in eGFR
The percentage of patients who, at Week 12, had at least a 30% reduction in UACR and less than a 30% decline in eGFR.
Change in albumin excretion rate from baseline.
Change in albumin excretion rate from baseline at Week 12.
The percentage of patients who achieved at least a 30% and at least a 50% reduction in UACR.
The percentage of patients who, at Week 12, had at least a 30% and at least a 50% reduction in UACR.
Change in log-transformed eGFR (based on the CKD-EPI combined creatinine-cystatin C equation) from baseline
Change in log-transformed eGFR (based on the CKD-EPI combined creatinine-cystatin C equation) from baseline at Week 12.
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Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
Lead sponsor
Weifang People's Hospital
Collaborator
Shenzhen HighTide Biopharmaceutical Ltd.
Collaborator
