Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT06714006
Eligibility Criteria:
Key Inclusion Criteria
1. Male or female aged 18 to 65 years (inclusive) at the time of informed consent.
2. ADPKD diagnosis as confirmed by the presence of genetic mutations associated with ADPKD, including, but not limited to, the presence of PKD1 mutation. Note: Where genotyping is not included the medical history for a participant, genotyping may be completed at Pre-Screening.
3. Class 1C, 1D, or 1E per Mayo Imaging Classification System for Predicting Kidney Outcomes in ADPKD (Irazabal et al. 2015) (based upon prior magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan obtained \> 6 months prior to Screening, or MRI obtained during Pre-Screening).
4. BMI ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg.
5. Non-smoker and must not have used any tobacco or nicotine products within 2 months prior to Screening.
6. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 via the CKD EPI 2021 calculation (Inker et al. 2021).
8\. Hematology and serum chemistry results at Screening that meet the following criteria:
1. Platelets \> 150 × 10\^9/L
2. Total white blood cell count \> 3.0 × 10\^9/L
3. Absolute neutrophil count \> 1.5 × 10\^9/L
4. Hemoglobin \> 110 g/L for females and \> 120 g/L for males
5. Total and direct bilirubin \< 1.5 × ULN, unless elevated bilirubin is associated with a known benign condition (e.g., Gilbert's syndrome)
6. Alanine aminotransferase (ALT) \< 1.5 × ULN
7. Aspartate aminotransferase (AST) \< 1.5 × ULN
8. Alkaline phosphatase (ALP) \< 1.5 × ULN
9. Gamma-glutamyl transferase \< 2 × ULN Note: Screening laboratory testing may be repeated once at the discretion of the PI or designee to confirm out-of-range(exclusionary) results.
Key Exclusion Criteria
1. Presence of potentially confounding genetic mutations (per genotyping by a NATA accredited or equivalent diagnostic laboratory)including, but not limited to, the presence of PKD2, HNF1B, GANAB, IFT140, and/or DNAJB 11 mutations. Note: Where genotyping is not included the medical history for a participant, genotyping may be completed at Pre-Screening.
2. Use of (or anticipated use of) Tolvaptan and/or metformin administration within 30 days prior to the first administration of IP until study completion.
3. Any renal or systemic pathology other than ADPKD or any other condition or prior therapy that in the opinion of the PI or designee would make the participant unsuitable for this study.
4. Has only 1 kidney or has a kidney transplant.
5. History of borderline to low blood magnesium and potassium levels and/or Screening or Day -1 blood magnesium level \< 0.7 mmol/L and potassium levels \< 3.5 mmol/L.
Note: Repeat testing (i.e., 1 repeat per parameter) at Screening or Day -1 is permitted for out-of-range values following approval by the PI or designee.
6. Proteinuria \> 500 milligrams per 24 hours.
7. Hematuria (urine albumin:creatinine ratio \> 30 mg/mmoL, or hematuria \> ++ on dipstick, or \> 100 cells per high-power field on microscopy)and/or urinary abnormalities at Screening deemed by the PI or designee to be of moderate or higher severity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06714006
Study Brief:
Protocol Section:
NCT06714006