Chronic Kidney DiseasePhase 1ZADIALNCT07741136
Pharmacokinetics of Zoledronic Acid in Patients on Dialysis
A Phase 1 study testing Zoledronic Acid Injection, 5.0 mg, single dose and Zoledronic Acid Injection, 2.5 mg, single dose in people with Chronic Kidney Disease and Osteoporosis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Osteoporosis, Dialysis
- What is being tested?
- Zoledronic Acid Injection, 5.0 mg, single dose and Zoledronic Acid Injection, 2.5 mg, single dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2026to 15 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years or older, with CKD-associated osteoporosis
- eGFR ≥ 35 mL/min/1.73 m2 and advanced CKD on dialysis
- Agree to participate in the research by signing the informed consent form
Who cannot join
- Individuals under 18 years of age, pregnant or breastfeeding women
- Patients with CKD with hypocalcemia/hypophsphatemia
- Patients with CKD on dialysis with residual diuresis > 100 mL/24h*
- Patients with CKD on low-flux membrane dialysis*
- Patients with neoplasia
- Hypersensitivity to bisphosphonates, or previous use of the medication
Show all 15Show fewer
- Inadequate oral condition or anticipated invasive dental procedure within the next 12 months
- Alkaline phosphatase < 98 IU/L or > 180 IU/L*
- PTH < 130 pg/mL and > 585 pg/mL*
- CTX < Lower Limit of Normal (LLN) or
- CTX < Upper Reference Limit (URL)*
- Severe liver disease
- Severe heart disease
- Clinical suspiction of osteomalacia or adynamic bone disease
- Cytopenias, defined as: platelets < 120,000/mm³, neutrophils < 3,000/mm³, lymphocytes < 1,000/mm³ and hematocrit < 26% * Applicable only to the group of patients undergoing dialysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
School of Medical Sciences, University of Campinas
Campinas, São Paulo, 13083-887
Rodrigo B de Oliveira, PhD, +55 19 35217366, rbo@unicamp.br
About this study
Official title: Pharmacokinetics of Zoledronic Acid in Patients With Chronic Kidney Disease on Dialysis
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.
- Conditions
- Chronic Kidney Disease, Osteoporosis, Dialysis
- Being tested
- Zoledronic Acid Injection, 5.0 mg, single dose, Zoledronic Acid Injection, 2.5 mg, single dose
- Keywords
- Zoledronic acid, bisphosphonate, Dialysis, Pharmacokinetics, Osteoporosis
- Medical subject headings
- Renal Insufficiency, Chronic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid Injection, 5.0 mg, single doseDrug
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 doseDrug
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 doseDrug
Zoledronic Acid Injection, 5.0 mg, single dose, for patients with CKD-associated osteoporosis on dialysis, at the beginning of dialysis session.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | CKD-associated osteoporosis in patients with eGFR >= 35 mL/min, allocated to receive conventional dose (5 mg, single dose). Receives: Drug: Zoledronic Acid Injection, 5.0 mg, single dose |
| CKD_Dialysis_2.5 | Experimental | CKD-associated osteoporosis in patients on dialysis, allocated to receive reduced dose (2.5 mg, single dose), at the beginning of dialysis session. Receives: Drug: Zoledronic Acid Injection, 2.5 mg, single dose |
| CKD_Dialysis_5.0 | Experimental | CKD-associated osteoporosis in patients on dialysis, allocated to receive conventional dose (5 mg, single dose), at the beginning of dialysis session. Receives: Drug: Zoledronic Acid Injection, 5.0 mg, single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of zoledronic acid (ng.mL/mL)
Area under the curve of the plasma concentration-time curve of zoledronic acid
Measured: From the start of dialysis session to ninety six hours (96 hours) post- drug administration.
Secondary outcomes (1)
Total mass of zoledronic acid extracted by the dialysis
Zoledronic acid mass (mg)
Measured: From the dialysis session start to the end of session at four hours (4h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- São Paulo State University
- Responsible party
- Principal investigator, Rodrigo Bueno de Oliveira, University of Campinas, Brazil
- Investigators
- Rodrigo B de Oliveira, PhD, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741136
- Sponsor's protocol ID
- 97356426.2.1001.5404
- Acronym
- ZADIAL
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Zoledronic Acid in Patients With Chronic Kidney Disease on Dialysis
- ClinicalTrials.gov ID
- NCT07741136
- Acronym / sponsor ID
- ZADIAL / 97356426.2.1001.5404
- Conditions
- Chronic Kidney Disease, Osteoporosis, Dialysis
- Keywords
- Zoledronic acid, bisphosphonate, Dialysis, Pharmacokinetics, Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- São Paulo State University
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Zoledronic Acid Injection, 5.0 mg, single doseCKD-associated osteoporosis in patients with eGFR >= 35 mL/min, allocated to receive conventional dose (5 mg, single dose). |
| CKD_Dialysis_2.5 | Experimental | Drug: Zoledronic Acid Injection, 2.5 mg, single doseCKD-associated osteoporosis in patients on dialysis, allocated to receive reduced dose (2.5 mg, single dose), at the beginning of dialysis session. |
| CKD_Dialysis_5.0 | Experimental | Drug: Zoledronic Acid Injection, 5.0 mg, single doseCKD-associated osteoporosis in patients on dialysis, allocated to receive conventional dose (5 mg, single dose), at the beginning of dialysis session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 years or older, with CKD-associated osteoporosis
- eGFR ≥ 35 mL/min/1.73 m2 and advanced CKD on dialysis
- Agree to participate in the research by signing the informed consent form
Key exclusion criteria (15 listed)
- Individuals under 18 years of age, pregnant or breastfeeding women
- Patients with CKD with hypocalcemia/hypophsphatemia
- Patients with CKD on dialysis with residual diuresis > 100 mL/24h*
- Patients with CKD on low-flux membrane dialysis*
- Patients with neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid Injection, 5.0 mg, single doseZoledronic Acid Injection, 5.0 mg, single dose for patients with CKD-associated osteoporosis with eGFR >= 35 mL/min. | Drug | Control group |
| Zoledronic Acid Injection, 2.5 mg, single doseZoledronic Acid Injection, 2.5 mg, single dose, for patients with CKD-associated osteoporosis on dialysis, at the beginning of dialysis session. | Drug | CKD_Dialysis_2.5 |
| Zoledronic Acid Injection, 5.0 mg, single doseZoledronic Acid Injection, 5.0 mg, single dose, for patients with CKD-associated osteoporosis on dialysis, at the beginning of dialysis session. | Drug | CKD_Dialysis_5.0 |
Primary outcome
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.
Area under the curve of the plasma concentration-time curve of zoledronic acid
1 secondary outcome
Total mass of zoledronic acid extracted by the dialysis
Time frame: From the dialysis session start to the end of session at four hours (4h)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo B de Oliveira, PhD principal investigator
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zoledronic Acid Injection, 5.0 mg, single dose and Zoledronic Acid Injection, 2.5 mg, single dose in people with Chronic Kidney Disease and Osteoporosis, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo B de Oliveira, PhD (+55 19 35217366, rbo@unicamp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.