Secondary HyperparathyroidismPhase 2CaT50HDNCT06398002
The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD
A Phase 2 study testing Dialysate calcium 1.50 mmol/L in people with Secondary Hyperparathyroidism and End-stage Kidney Disease, run by Iain Bressendorff.
Trial summary
Patients with end-stage kidney disease (ESKD) have an increased risk of cardiovascular mortality. High parathyroid hormone (PTH) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, End-stage Kidney Disease
- What is being tested?
- Dialysate calcium 1.50 mmol/L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years.
- Treatment with thrice-weekly maintenance HD for ESKD for > 3 months.
- Dialysate calcium of 1.25 mmol/L (standard concentration).
- Plasma ionised calcium < 1.35 mmol/L (average of last 3 months).
- Plasma intact PTH > 14 ρmol/L.
- Plasma total alkaline phosphatase >90 U/L
- Negative pregnancy test and use of highly effective and safe contraception.
- Able to give written informed consent.
Who cannot join
- Treatment with peritoneal dialysis.
- Clinical bone fracture within the last 6 months.
- Treatment with bisphosphonates, denosumab, romosozumab, or teriparatide within the last 3 months.
- Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Increasing Dialysate Calcium on Serum Calcification Propensity in Subjects With Secondary Hyperparathyroidism and End-Stage Kidney Disease
Patients with end-stage kidney disease (ESKD) have an increased risk of cardiovascular mortality. High parathyroid hormone (PTH) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. The main driving factor for secondary hyperparathyroidism is hypocalcaemia caused by low levels of 1,25-dihydroxy vitamin D and pharmacological supplementation with activated vitamin D and oral calcium-containing phosphate-binders are used to control secondary hyperparathyroidism. The amount of calcium used in this context is controversial, as higher calcium load in blood may theoretically increase vascular calcification. Conversely, by alleviating the efflux of phosphate and calcium from bone due to secondary hyperparathyroidism, increasing the load of calcium might actually prevent vascular calcification.
To study this further, we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate Ca from 1.25 mmol/L (standard dialysate concentration) to 1.50 mmol/L in patients with ESKD and secondary hyperparathyroidism on maintenance haemodialysis (HD). The overall effect of increased dialysate calcium will be gauged by its effect on serum calcification propensity (T50) and on markers of bone turnover.
- Being tested
- Dialysate calcium 1.50 mmol/L
- Medical subject headings
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate calcium 1.50 mmol/LOther
Increased dialysate calcium of 1.50 mmol/L (as compared to standard dialysate calcium of 1.25 mmol/L)
| Study group | Role | What they receive |
|---|---|---|
| Dialysate calcium 1.25 mmol/L (standard) | Active comparator | Not described Receives: Other: Dialysate calcium 1.50 mmol/L |
| Dialysate calcium 1.50 mmol/L (high) | Experimental | Not described Receives: Other: Dialysate calcium 1.50 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in serum calcification propensity (T50)
Between-groups difference in T50 at day 28 adjusted for T50 at day 0
Measured: 28 days
Secondary outcomes (11)
Difference in bone-specific alkaline phosphatase (bALP)
Between-groups difference in bALP at day 28 adjusted for bALP at day 0
Measured: 28 days
Difference in procollagen 1 intact N-terminal propeptide (P1NP)
Between-groups difference in P1NP at day 28 adjusted for P1NP at day 0
Measured: 28 days
Difference in tartrate-resistant acid phosphatase 5b (TRAcP 5b)
Between-groups difference in TRAcP 5b at day 28 adjusted for TRAcP 5b at day 0
Measured: 28 days
Difference in parathyroid hormone (PTH)
Between-groups difference in PTH at day 28 adjusted for PTH at day 0
Measured: 28 days
Difference in calciprotein monomers (CPM)
Between-groups difference in CPM at day 28 adjusted for CPM at day 0
Measured: 28 days
Difference in primary calciprotein particles (CPP-1)
Between-groups difference in CPP-1 at day 28 adjusted for CPP-1 at day 0
Measured: 28 days
Difference in primary calciprotein particles (CPP-2)
Between-groups difference in CPP-2 at day 28 adjusted for CPP-2 at day 0
Measured: 28 days
Difference in plasma ionised calcium (iCa)
Between-groups difference in iCa at day 28 adjusted for iCa at day 0
Measured: 28 days
Difference in plasma phosphate (PO4)
Between-groups difference in PO4 at day 28 adjusted for PO4 at day 0
Measured: 28 days
Difference in plasma magnesium (Mg)
Between-groups difference in Mg at day 28 adjusted for Mg at day 0
Measured: 28 days
Difference in all above variables
Within-groups difference in all above variables at day 28 adjusted for values at day 0
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind, parallel-group, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iain Bressendorff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iain Bressendorff, Herlev Hospital
- Investigators
- Iain Bressendorff, MD PhD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398002
- Sponsor's protocol ID
- CaT50HD
- Acronym
- CaT50HD
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request to the investigators
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Increasing Dialysate Calcium on Serum Calcification Propensity in Subjects With Secondary Hyperparathyroidism and End-Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT06398002
- Acronym / sponsor ID
- CaT50HD / CaT50HD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Iain BressendorffUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 3 May 2024 (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.
Patients with end-stage kidney disease (ESKD) have an increased risk of cardiovascular mortality. High parathyroid hormone (PTH) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. The main driving factor for secondary hyperparathyroidism is hypocalcaemia caused by low levels of 1,25-dihydroxy vitamin D and pharmacological supplementation with activated vitamin D and oral calcium-containing phosphate-binders are used to control secondary hyperparathyroidism. The amount of calcium used in this context is controversial, as higher calcium load in blood may theoretically increase vascular calcification. Conversely, by alleviating the efflux of phosphate and calcium from bone due to secondary hyperparathyroidism, increasing the load of calcium might actually prevent vascular calcification.
To study this further, we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate Ca from 1.25 mmol/L (standard dialysate concentration) to 1.50 mmol/L in patients with ESKD and secondary hyperparathyroidism on maintenance haemodialysis (HD). The overall effect of increased dialysate calcium will be gauged by its effect on serum calcification propensity (T50) and on markers of bone turnover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, double-blind, parallel-group, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dialysate calcium 1.25 mmol/L (standard) | Active comparator | Other: Dialysate calcium 1.50 mmol/L |
| Dialysate calcium 1.50 mmol/L (high) | Experimental | Other: Dialysate calcium 1.50 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Treatment with thrice-weekly maintenance HD for ESKD for > 3 months.
- Dialysate calcium of 1.25 mmol/L (standard concentration).
- Plasma ionised calcium < 1.35 mmol/L (average of last 3 months).
- Plasma intact PTH > 14 ρmol/L.
Key exclusion criteria (5 listed)
- Treatment with peritoneal dialysis.
- Clinical bone fracture within the last 6 months.
- Treatment with bisphosphonates, denosumab, romosozumab, or teriparatide within the last 3 months.
- Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Dialysate calcium 1.50 mmol/LIncreased dialysate calcium of 1.50 mmol/L (as compared to standard dialysate calcium of 1.25 mmol/L) | Other | Dialysate calcium 1.25 mmol/L (standard), Dialysate calcium 1.50 mmol/L (high) |
Primary outcome
Difference in serum calcification propensity (T50)
Time frame: 28 days
Between-groups difference in T50 at day 28 adjusted for T50 at day 0
11 secondary outcomes
Difference in bone-specific alkaline phosphatase (bALP)
Time frame: 28 days
Difference in procollagen 1 intact N-terminal propeptide (P1NP)
Time frame: 28 days
Difference in tartrate-resistant acid phosphatase 5b (TRAcP 5b)
Time frame: 28 days
Difference in parathyroid hormone (PTH)
Time frame: 28 days
Difference in calciprotein monomers (CPM)
Time frame: 28 days
Difference in primary calciprotein particles (CPP-1)
Time frame: 28 days
Difference in primary calciprotein particles (CPP-2)
Time frame: 28 days
Difference in plasma ionised calcium (iCa)
Time frame: 28 days
Difference in plasma phosphate (PO4)
Time frame: 28 days
Difference in plasma magnesium (Mg)
Time frame: 28 days
Difference in all above variables
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: Yes. Upon reasonable request to the investigators
Related trials for Secondary Hyperparathyroidism
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REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
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Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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Strategies for Proactive Health in People With Kidney Function Decline
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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. This study is not recruiting at the moment.
Iain Bressendorff, MD PhD principal investigator
Herlev and Gentofte Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dialysate calcium 1.50 mmol/L in people with Secondary Hyperparathyroidism and End-stage Kidney Disease, run by Iain Bressendorff.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iain Bressendorff, MD PhD (+4524277139, iain.oshoej.bressendorff@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in serum calcification propensity (T50) (time frame: 28 days). 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 3 May 2024.