CKD, T2DM
Conditions
Brief summary
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.
Interventions
DRUGHTD1801
1000mg (as 4 capsules), twice a day for 12 weeks
OTHERplacebo
4 placebo capsules, twice a day for 12 weeks.
Sponsors
Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
Weifang People's Hospital
Shenzhen HighTide Biopharmaceutical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Subjects must meet all of the following criteria to be eligible for the study: 1. Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form. 2. Clinically diagnosed with Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD) before screening, evidenced by: 1. A urine albumin-to-creatinine ratio (UACR) \>200 mg/g on at least two separate occasions before screening. 2. 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). 3. 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%. 4. At screening, on a stable, maximum tolerated or recommended dose of a RAAS inhibitor (e.g., valsartan, irbesartan) for at least 4 weeks. If not on a RAAS inhibitor, must be on at least one other stable, guideline-recommended kidney-protective drug (e.g., GLP-1RA, SGLT-2i, or non-steroidal MRA like finerenone) for at least 4 weeks. 5. Body Mass Index (BMI) at screening between 18.5 kg/m² and 40 kg/m². Weight must be stable (no loss \>10% in the 3 months before baseline) with no major lifestyle changes in the 3 months before screening. 6. For women of childbearing potential and sexually active men with partners of childbearing potential: agreement to use highly effective contraception or practice abstinence throughout the study and for 30 days after the last dose. 7. Able to understand, sign the informed consent form, and comply with the study protocol.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in urine albumin-to-creatinine ratio (UACR) from baseline | 12 weeks | Relative change in urine albumin-to-creatinine ratio (UACR) from baseline at Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving a ≥30% reduction in UACR and a <30% decline in eGFR | 12 weeks | 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. | 12 weeks | 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. | 12 weeks | 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 | 12 weeks | Change in log-transformed eGFR (based on the CKD-EPI combined creatinine-cystatin C equation) from baseline at Week 12. |
| Change in log-transformed eGFR (based on the CKD-EPI cystatin C equation) from baseline. | 12 weeks | Change in log-transformed eGFR (based on the CKD-EPI cystatin C equation) from baseline at Week 12. |
| Change in log-transformed eGFR (based on the CKD-EPI creatinine equation) from baseline. | 12 weeks | Change in log-transformed eGFR (based on the CKD-EPI creatinine equation) from baseline at Week 12. |
| Rate of change in eGFR slope (based on the CKD-EPI creatinine-cystatin C equation) from baseline. | 12 weeks | Rate of change in eGFR slope (based on the CKD-EPI creatinine-cystatin C equation) from baseline at Week 12. |
| Rate of change in eGFR slope (based on the CKD-EPI cystatin C equation) from baseline. | 12 weeks | Rate of change in eGFR slope (based on the CKD-EPI cystatin C equation) from baseline at Week 12. |
| Rate of change in eGFR slope (based on the CKD-EPI creatinine equation) from baseline. | 12 weeks | Rate of change in eGFR slope (based on the CKD-EPI creatinine equation) from baseline at Week 12. |
| Absolute and percent change in C-reactive protein (CRP) from baseline. | 12 weeks | Absolute and percent change in C-reactive protein (CRP) from baseline at Week 12. |
| Absolute and percent change in Gamma-glutamyl transferase (GGT) from baseline. | 12 weeks | Absolute and percent change in Gamma-glutamyl transferase (GGT) from baseline at Week 12. |
| Absolute and percent change in Hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline. | 12 weeks | Absolute and percent change in Hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline at Week 12. |
| Absolute and percent change in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline. | 12 weeks | Absolute and percent change in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline at Week 12. |
Countries
China
Contacts
CONTACTZhen Shen
CONTACTXingpeng Shi
STUDY_DIRECTORJiandong Jiang
Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
PRINCIPAL_INVESTIGATORLulu Wang
Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
Outcome results
None listed