A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With T… (NCT07496177) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chronic Kidney Disease.
China75 participantsStarted 2026-05-01
Plain-language 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:
â–ª 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
✓. Clinically diagnosed with Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD) before screening, evidenced by:
✓. 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%.
✓. 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.
✓. 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.
What they're measuring
1
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline
Timeframe: 12 weeks
Trial details
NCT IDNCT07496177
SponsorInstitute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
. 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.
Exclusion criteria
✕. 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).
✕. History of hepatic decompensation (e.g., ascites, hepatic encephalopathy, or variceal bleeding).
✕. Presence of the following acute or chronic liver diseases at screening: autoimmune hepatitis, primary biliary cholangitis, alcoholic liver disease, Wilson's disease, or drug-induced liver injury.
✕. History of gastric bypass surgery.
✕. History of peptic or gastrointestinal ulcer within 12 months prior to randomization.
✕. History of clinically active inflammatory bowel disease within 12 months prior to randomization.