Pharmacokinetics of Zoledronic Acid in Patients on Dialysis

Sponsor
University of Campinas, Brazil
Study ID
NCT07741136
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zoledronic Acid Injection, 5.0 mg, single dose — DRUG
    Zoledronic Acid Injection, 5.0 mg, single dose for patients with CKD-associated osteoporosis with eGFR \>= 35 mL/min.
  • Zoledronic Acid Injection, 2.5 mg, single dose — DRUG
    Zoledronic Acid Injection, 2.5 mg, single dose, for patients with CKD-associated osteoporosis on dialysis, at the beginning of dialysis session.
  • Zoledronic Acid Injection, 5.0 mg, single dose — DRUG
    Zoledronic Acid Injection, 5.0 mg, single dose, for patients with CKD-associated osteoporosis on dialysis, at the beginning of dialysis session.

Study Details

Osteoporosis is a frequent complication of chronic kidney disease (CKD) on dialysis, with an estimated prevalence of approximately 40%. It is associated with increased fracture risk, reduced quality of life, and higher mortality. Despite available therapies, management often remains suboptimal, partly due to limited evidence on the safety and pharmacokinetics of bisphosphonates in this population. Objectives: To understand the pharmacokinetics of zoledronic acid in CKD patients on dialysis, as well as to analyze its effects on biomarkers of bone metabolism, bone mineral density (BMD), and clinical outcomes. Materials and Methods: This prospective clinical study involves 24 adult individuals, 8 with CKD-associated osteoporosis (control group; estimated glomerular filtration rate (eGFR) ≥ 35 mL/min/1.73 m²) and 16 with CKD-associated osteoporosis anuric on dialysis patients. Individuals undergoing dialysis will be assigned to receive zoledronic acid at doses of 2.5 mg or 5 mg intravenously (single dose, at the beggining of dialysis session), while patients with CKD-associated osteoporosis (control group; estimated glomerular filtration rate (eGFR) ≥ 35 mL/min/1.73 m²) will receive 5 mg, also in a single dose. Serial blood samples will be collected after infusion, during dialysis session and again up to 96h after dialysis session initiation. The dialysate will be continuously sampled in a tank and aliquots collected for further analysis. The plasma levels of zoledronic acid will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry. The primary outcome is the plasma concentration-time curve of zoledronic acid during a regular dialysis session. Secondary outcomes are: (i) plasma concentration of zoledronic acid up to 96h;(ii) the total mass of zoledronic acid extracted by the dialysate; (iii) the dialytic clearance of zoledronic acid. Evaluation of bone biomarkers (e.g., PTH, alkaline phosphatase, calcium, phosphorus, CTX, and P1NP) and BMD (assessed by bone densitometry) will be performed at baseline and at 12 months. The study will be conducted at the UNICAMP Clinical Hospital, with the participation of one participating center, subject to prior approval from the respective Research Ethics Committees. All participants will be included only after signing the Informed Consent Form. Data will be anonymized and processed in accordance with the General Data Protection Law (LGPD). Expected results: To characterize the pharmacokinetic profile and establish the best dosage regimen of zoledronic acid in patients with CKD on dialysis; to observe the impact of the drug on biomarkers of bone metabolism and BMD.

Key Dates

First listed
Aug 3, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Aug 15, 2027
Completion
Aug 15, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    CKD-associated osteoporosis in patients with eGFR \>= 35 mL/min, allocated to receive conventional dose (5 mg, single dose).
  • Experimental: CKD_Dialysis_2.5
    CKD-associated osteoporosis in patients on dialysis, allocated to receive reduced dose (2.5 mg, single dose), at the beginning of dialysis session.
  • Experimental: CKD_Dialysis_5.0
    CKD-associated osteoporosis in patients on dialysis, allocated to receive conventional dose (5 mg, single dose), at the beginning of dialysis session.

Primary Outcome Measure

Area Under the Curve of zoledronic acid (ng.mL/mL) [ Time Frame: From the start of dialysis session to ninety six hours (96 hours) post- drug administration. ]

Central Contacts

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