Kidney DiseasesPhase 4PREFERRED-1NCT05096195
PRevEnting FracturEs in REnal Disease - 1
A Phase 4 study testing Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis and Monitoring of post-injection calcium and phosphate in people with Kidney Diseases and Dialysis; Complications, run by Western University, Canada at 6 sites in Canada.
Trial summary
PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Kidney Diseases, Dialysis; Complications, Fragility Fracture
- What is being tested?
- Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis and Monitoring of post-injection calcium and phosphate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesCanada
- Study dates
- 11 Jun 2022to Dec 2025
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treating nephrologist/nurse practitioner in the dialysis unit deems that a prescription for study drug (denosumab) will be safe/reasonable in the potential participant.
- Age ≥40 years
- Access to denosumab through provincial drug benefits (i.e. evidence of receiving outpatient prescription medications through the Ontario Drug Benefits Program, Ontario Disability Support Program)
- Baseline albumin-corrected serum calcium ≥2.15 mmol/L, PTH ≥15 pmol/L (or 2-9x the upper limit of normal for the local laboratory).
- High risk of fragility fracture defined by: a) ≥15% 10-year risk of major osteoporotic fracture or >3% 10-year risk of hip fracture (using the World Health Organization's Fracture Risk Assessment Tool which is validated in hemodialysis),OR b) a prior history of hip or vertebral fracture (where the later could have been asymptomatic and only observed radiographically), OR c) two or more fragility fractures of the humerus, wrist, and/or pelvis (e.g. 2 humerus fractures, humerus and wrist fracture).43
Who cannot join
- Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transfer to home or peritoneal dialysis within 12 months (as assessed by a health professional).
- Expected to start IV bisphosphonates (i.e. pamidronate or zoledronic acid).
- Current use of cinacalcet (Sensipar).
- Current use of an osteoporosis medication including:
- Denosumab
- Bisphosphonates
Show all 20Show fewer
- Alendronate (Fosavance or Fosamax)
- Risedronate (Actonel or Actonel DR)
- Zoledronic acid (Aclasta) or Pamidronate
- Raloxifene (Evista)
- Oral or conjugated estrogen
- Topical, oral or injectable testosterone (Androgel, Testim, Fortesta, Androderm, testosterone enanthate and testosterone cypionate)
- Teriperatide (Forteo)
- Romosozumab (Evenity)
- Calcitonin (Calcimar)
- Of childbearing status
- History of femur fracture attributed to osteoporosis medication use (i.e. midshaft femoral fracture or atypical femoral fracture)
- Major dental surgery planned within the next 6 months (e.g. root canal).
- Known allergy or intolerance to denosumab.
- Expected to receive a parathyroidectomy for hyperparathyroidism in the next 12 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Huron Perth Healthcare Alliance - Stratford General Hospital
Stratford, Ontario, N5A 2Y6
St. Michaels Hospital
Toronto, Ontario, M5B 1W8
Woodstock Hospital
Woodstock, Ontario, N4V 0A4
About this study
Official title: Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care
PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. The pilot study will enroll at least 60 patients from across at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care.
Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.
Read the detailed description
Despite a fragility fracture risk that is >5-fold higher than those without chronic kidney disease (CKD), there is a lack of evidence on how to prevent fracture in patients on hemodialysis. Medications known to prevent fragility fracture in other populations, are either contraindicated in dialysis, or associated with severe side effects.
Denosumab (Prolia) is one of the only Health Canada approved medications for fragility fracture prevention across the CKD stages. While small clinical trials inclusive of hemodialysis patients have noted that denosumab improves bone mineral density and reduces bone turnover, whether this treatment effectively and safely prevents fragility fracture in this population still remains unclear.
Instead of conducting an expensive traditional RCT where results might fail to apply to the "real-world", the study will embed a trial of denosumab into routine care. The intervention will be delivered by healthcare staff. Participants will be closely followed at the dialysis unit where the participant has dialysis treatments. Baseline characteristics and outcomes will be captured using routine care data including administrative health data.
The overarching aim of the PREFERRED Program is to determine whether a denosumab care pathway vs. usual care (i.e., non-use of denosumab) alters the risk of fragility fracture in patients receiving in-centre hemodialysis. PREFERRED-1 is a pilot study that will inform the feasibility of conducting a large-scale, efficiently run, randomized-controlled trial in Canada to test whether denosumab reduces the risk of fragility fracture in patients receiving hemodialysis. The goal is to understand if individual level recruitment is feasible and timely, and if the intervention is acceptable to patients.
The objectives of PREFERRED-1 are to:
- Examine whether streamlined methods of enrollment can facilitate recruitment across multiple centres in a timely way;
- Demonstrate good adherence with the trial protocol and examine whether well-received by participants;
- Ensure that participants are adherent with treatment assignment (i.e., intervention group to denosumab, minimal cross-over to denosumab in usual group);
- Confirm there are no 'signals' of unmanageable harm (i.e. hypocalcemia) that would prevent testing of our intervention on a larger scale.
PREFERRED-1 will be deemed a success if:
- The study can randomly allocate at least 60 patients from at least 6 hemodialysis centres within 6-months of the trial being activated at each centre.
- Demonstrate that patients randomly allocated to denosumab receive over 90% of the scheduled injections at 0, 6 and 12 months
- Patients randomly allocated to no denosumab (i.e. usual care) do not receive a prescription for denosumab.
This "high-risk" innovative pragmatically approached trial focused on better treatments for fracture prevention in those with kidney disease will
- inform transformational change in the care of real-world patients;
- produce essential knowledge to safely prevent fracture in patients with kidney disease, and the associated costs to the healthcare system;
- foster the conduct of collaborative, multidisciplinary care for those with complex kidney disease.
- Conditions
- Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder
- Being tested
- Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate
- Keywords
- Pilot Study, Fracture, denosumab, hemodialysis
- Medical subject headings
- Kidney Diseases, Chronic Kidney Disease-Mineral and Bone Disorder, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 60 mg/mlDrug
Also called Prolia
Details described in intervention arm/group description section.
Calcium and vitamin D prophylaxisOther
Details described in intervention arm/group description section.
Monitoring of post-injection calcium and phosphateDiagnostic test
Details described in intervention arm/group description section.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 60 mg of denosumab (Prolia) will be administered every 6 months over a 15 - month period. Monitoring of serum calcium and phosphate will occur and bloodwork will be drawn for 7 weeks following each denosumab injection. Correction of vitamin D deficiency (if required), the adjustment of calcium dialysate and the provision of intravenous (IV) or oral (po) calcitriol/calcidiol will be administered as needed following each denosumab injection as described in the Beside Protocol. Once the study monitoring period is over, serum calcium monitoring and management will occur as per routine care in the dialysis centre. All intervention activities will occur during regularly scheduled hemodyalisis sessions. Receives: Drug: Denosumab 60 mg/ml; Other: Calcium and vitamin D prophylaxis; Diagnostic Test: Monitoring of post-injection calcium and phosphate |
| Usual care | No intervention | Usual care participants will continue to receive the typical standard of care in their dialysis unit which includes their routine dialysis monitoring and bloodwork. They will not receive denosumab, calcium and vitamin prophylaxis. There will be no extra monitoring or bloodwork. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number or N (%) of participants randomly allocated within 26 weeks of trial initiation at each centre.
Measured: 26 weeks
Adherence to study intervention
Number (%) of participants randomized to the intervention who received >90% of their scheduled treatments to study end.
Measured: 15 months
Adherence to usual care
Number (%) of participants randomized to usual care who received no prescription for denosumab to study end.
Measured: 15 months
Secondary outcomes (8)
Treatment-related hypocalcemia as assessed by CTCAE v4.0
N (%) with hypocalcemia and symptomatic hypocalcemia [graded according to common terminology criteria for adverse events v 4.0 criteria (Grade 2, albumin-corrected serum calcium 1.75 to 1.99 mmol/L, Grade 3, 1.5 to 1.74 mmol/L, Grade 4, serum calcium <1.5 mmol/L)] within 7 weeks of denosumab. Symptomatic hypocalcemia will be defined by a calcium <2.00 mmol/L in the presence of new muscle cramps or paresthesia.
Measured: within 7 weeks following denosumab injection
Mean change in serum calcium
Mean change in serum calcium from baseline to 7 weeks post injection
Measured: 7 weeks following denosumab injection
Median change in serum calcium
Median change in serum calcium from baseline to 7 weeks post injection
Measured: 7 weeks following denosumab injection
Mean change in parathyroid hormone
Mean change in parathyroid hormone from baseline to 7 weeks post injection
Measured: 7 weeks following denosumab injection
Median change in parathyroid hormone
Median change in parathyroid hormone from baseline to 7 weeks post injection
Measured: 7 weeks following denosumab injection
Fragility fracture
N (%) with hospital encounter for fragility fracture of the hip, vertebrae, humerus, wrist, or pelvis at 15 months
Measured: 15 months
Satisfaction with E-Platform and E-Consent Process
Patient satisfaction with e-platform, and e-consent process. (Likert Scale with 1=not satisfied to 5=very satisfied)
Measured: 15 months
Satisfaction with intervention
Patient satisfaction with intervention (Likert Scale with 1=not satisfied, 5=very satisfied)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start11 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- ICES, Academic Medical Organization of Southwestern Ontario, Western University, The Kidney Foundation of Canada
- Responsible party
- Principal investigator, Kristin Clemens, Western University, Canada
- Investigators
- Kristin K Clemens, MD, MSc, Principal investigator, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096195
- Sponsor's protocol ID
- 3638
- Acronym
- PREFERRED-1
- Status last verified
- May 2025
- First submitted
- 21 Sep 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clemens KK, Cowan A, Dixon S, Naylor K, Weir MA, Thain J, Khan T, Silver S, Molnar AO, Sultan N, Holden RM, Hiremath S, Wald R, Kitchlu A, Arnold J, Field B, Garg AX. PRevEnting FracturEs in REnal Disease-1 (PREFERRED-1): protocol for a pilot study of a pragmatic, randomised controlled trial of denosumab for the prevention of fragility fractures in haemodialysis. BMJ Open. 2025 Sep 10;15(9):e097195. doi: 10.1136/bmjopen-2024-097195.
PubMed 40935429
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care
- ClinicalTrials.gov ID
- NCT05096195
- Acronym / sponsor ID
- PREFERRED-1 / 3638
- Conditions
- Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder
- Keywords
- Pilot Study, Fracture, denosumab, hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- ICES, Academic Medical Organization of Southwestern Ontario, Western University, The Kidney Foundation of Canada
- Study start
- 11 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Oct 2021 (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.
PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. The pilot study will enroll at least 60 patients from across at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care.
Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.
Detailed description
Despite a fragility fracture risk that is >5-fold higher than those without chronic kidney disease (CKD), there is a lack of evidence on how to prevent fracture in patients on hemodialysis. Medications known to prevent fragility fracture in other populations, are either contraindicated in dialysis, or associated with severe side effects.
Denosumab (Prolia) is one of the only Health Canada approved medications for fragility fracture prevention across the CKD stages. While small clinical trials inclusive of hemodialysis patients have noted that denosumab improves bone mineral density and reduces bone turnover, whether this treatment effectively and safely prevents fragility fracture in this population still remains unclear.
Instead of conducting an expensive traditional RCT where results might fail to apply to the "real-world", the study will embed a trial of denosumab into routine care. The intervention will be delivered by healthcare staff. Participants will be closely followed at the dialysis unit where the participant has dialysis treatments. Baseline characteristics and outcomes will be captured using routine care data including administrative health data.
The overarching aim of the PREFERRED Program is to determine whether a denosumab care pathway vs. usual care (i.e., non-use of denosumab) alters the risk of fragility fracture in patients receiving in-centre hemodialysis. PREFERRED-1 is a pilot study that will inform the feasibility of conducting a large-scale, efficiently run, randomized-controlled trial in Canada to test whether denosumab reduces the risk of fragility fracture in patients receiving hemodialysis. The goal is to understand if individual level recruitment is feasible and timely, and if the intervention is acceptable to patients.
The objectives of PREFERRED-1 are to:
- Examine whether streamlined methods of enrollment can facilitate recruitment across multiple centres in a timely way;
- Demonstrate good adherence with the trial protocol and examine whether well-received by participants;
- Ensure that participants are adherent with treatment assignment (i.e., intervention group to denosumab, minimal cross-over to denosumab in usual group);
- Confirm there are no 'signals' of unmanageable harm (i.e. hypocalcemia) that would prevent testing of our intervention on a larger scale.
PREFERRED-1 will be deemed a success if:
- The study can randomly allocate at least 60 patients from at least 6 hemodialysis centres within 6-months of the trial being activated at each centre.
- Demonstrate that patients randomly allocated to denosumab receive over 90% of the scheduled injections at 0, 6 and 12 months
- Patients randomly allocated to no denosumab (i.e. usual care) do not receive a prescription for denosumab.
This "high-risk" innovative pragmatically approached trial focused on better treatments for fracture prevention in those with kidney disease will
- inform transformational change in the care of real-world patients;
- produce essential knowledge to safely prevent fracture in patients with kidney disease, and the associated costs to the healthcare system;
- foster the conduct of collaborative, multidisciplinary care for those with complex kidney disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Denosumab 60 mg/ml, Other: Calcium and vitamin D prophylaxis, Diagnostic Test: Monitoring of post-injection calcium and phosphate60 mg of denosumab (Prolia) will be administered every 6 months over a 15 - month period. Monitoring of serum calcium and phosphate will occur and bloodwork will be drawn for 7 weeks following each denosumab injection. Correction of vitamin D deficiency (if required), the adjustment of calcium dialysate and the provision of intravenous (IV) or oral (po) calcitriol/calcidiol will be administered as needed following each denosumab injection as described in the Beside Protocol. Once the study monitoring period is over, serum calcium monitoring and management will occur as per routine care in the dialysis centre. All intervention activities will occur during regularly scheduled hemodyalisis sessions. |
| Usual care | No intervention | –Usual care participants will continue to receive the typical standard of care in their dialysis unit which includes their routine dialysis monitoring and bloodwork. They will not receive denosumab, calcium and vitamin prophylaxis. There will be no extra monitoring or bloodwork. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Treating nephrologist/nurse practitioner in the dialysis unit deems that a prescription for study drug (denosumab) will be safe/reasonable in the potential participant.
- Age ≥40 years
- Access to denosumab through provincial drug benefits (i.e. evidence of receiving outpatient prescription medications through the Ontario Drug Benefits Program, Ontario Disability Support Program)
- Baseline albumin-corrected serum calcium ≥2.15 mmol/L, PTH ≥15 pmol/L (or 2-9x the upper limit of normal for the local laboratory).
- High risk of fragility fracture defined by: a) ≥15% 10-year risk of major osteoporotic fracture or >3% 10-year risk of hip fracture (using the World Health Organization's Fracture Risk Assessment Tool which is validated in hemodialysis),OR b) a prior history of hip or vertebral fracture (where the later could have been asymptomatic and only observed radiographically), OR c) two or more fragility fractures of the humerus, wrist, and/or pelvis (e.g. 2 humerus fractures, humerus and wrist fracture).43
Key exclusion criteria (20 listed)
- Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transfer to home or peritoneal dialysis within 12 months (as assessed by a health professional).
- Expected to start IV bisphosphonates (i.e. pamidronate or zoledronic acid).
- Current use of cinacalcet (Sensipar).
- Current use of an osteoporosis medication including:
- Of childbearing status
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 |
|---|---|---|
| Denosumab 60 mg/mlAlso: ProliaDetails described in intervention arm/group description section. | Drug | Intervention |
| Calcium and vitamin D prophylaxisDetails described in intervention arm/group description section. | Other | Intervention |
| Monitoring of post-injection calcium and phosphateDetails described in intervention arm/group description section. | Diagnostic test | Intervention |
Primary outcome
Recruitment rate
Time frame: 26 weeks
Number or N (%) of participants randomly allocated within 26 weeks of trial initiation at each centre.
Adherence to study intervention
Time frame: 15 months
Number (%) of participants randomized to the intervention who received >90% of their scheduled treatments to study end.
Adherence to usual care
Time frame: 15 months
Number (%) of participants randomized to usual care who received no prescription for denosumab to study end.
8 secondary outcomes
Treatment-related hypocalcemia as assessed by CTCAE v4.0
Time frame: within 7 weeks following denosumab injection
Mean change in serum calcium
Time frame: 7 weeks following denosumab injection
Median change in serum calcium
Time frame: 7 weeks following denosumab injection
Mean change in parathyroid hormone
Time frame: 7 weeks following denosumab injection
Median change in parathyroid hormone
Time frame: 7 weeks following denosumab injection
Fragility fracture
Time frame: 15 months
Satisfaction with E-Platform and E-Consent Process
Time frame: 15 months
Satisfaction with intervention
Time frame: 15 months
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 31 May 2025.
- Derived from this study: PubMed 40935429Clemens KK, Cowan A, Dixon S, Naylor K, Weir MA, Thain J, Khan T, Silver S, Molnar AO, Sultan N, Holden RM, Hiremath S, Wald R, Kitchlu A, Arnold J, Field B, Garg AX. PRevEnting FracturEs in REnal Disease-1 (PREFERRED-1): protocol for a pilot study of a pragmatic, randomised controlled trial of denosumab for the prevention of fragility fractures in haemodialysis. BMJ Open. 2025 Sep 10;15(9):e097195. doi: 10.1136/bmjopen-2024-097195.
- Individual participant dataSharing planned: No
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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. This study is not recruiting at the moment.
Kristin K Clemens, MD, MSc principal investigator
St. Joseph's Health Care London
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis and Monitoring of post-injection calcium and phosphate in people with Kidney Diseases and Dialysis; Complications, run by Western University, Canada at 6 sites in Canada.
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 5 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 26 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096195, which also lists 1 linked publication.
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 31 May 2025.