P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease (NCT06489340) | Clinical Trial Compass
WithdrawnPhase 2
P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease
Stopped: Withdrawn due to patient enrollment challenges
United States0Started 2025-06-11
Plain-language summary
This is an open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) given intravenously in adult patients with type 2 diabetes with diabetic kidney disease (DKD) and proteinuria.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Capable of giving and has provided a signed Informed Consent Form (ICF).
✓. Male or female age 18 to 75 years inclusive, at the time of signing the informed consent.
✓. Women of childbearing potential (WOCBP) and male subjects who are partners of WOCBP must agree to use an acceptable form of contraception during the study and for 30 days following the last dose of study drug.
✓. Clinical diagnosis of type 2 diabetes as per guidelines.
✓. Clinical diagnosis of diabetic kidney disease in the opinion of the principal investigator, or renal biopsy proven diabetic kidney disease without evidence of additional pathologic findings of alternative diagnosis.
✓. At screening, based on two 24-hour urine collections, geometric mean of two urinary albumin creatine ratios (UACR) ≥ 400 mg/g and ≤ 3500 mg/g.
✓. At screening, eGFR equal or greater than 30 and less than 90 mL/min/1.73 m\^2.
✓. Body mass index (BMI) ≤ 40.0 kg/m\^2.
Exclusion criteria
✕. Has a solitary kidney.
✕. Has a positive drug screen.
✕. Known kidney disease other than diabetic kidney disease.
✕. End stage renal disease (ESRD) (i.e., peritoneal dialysis, hemodialysis, or history of kidney transplantation).
What they're measuring
1
Percent change in 24-hour urinary albumin to creatinine ratio (UACR)
Timeframe: From Day 1 (baseline) to Week 12 (end of treatment)
2
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
✕. Acute kidney injury or dialysis within the last 3 months before the screening visit.
✕. Uncontrolled diabetes as defined by HbA1c \>10 at screening.
✕. Uncontrolled hypertension with systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg during screening.
✕. Unstable cardiovascular disease or history of myocardial infarction or arterial thromboembolic events within 3 months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval \>480 msec.