Sodium Zirconium CyclosilicatePhase 3SZCNCT05382988
Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
A Phase 3 study testing Sodium zirconium cyclosilicate in people with Sodium Zirconium Cyclosilicate and Hyperkalemia, run by Guangdong Provincial People's Hospital.
Trial summary
Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients. However, the effects of SZC during the perioperative period remained unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sodium Zirconium Cyclosilicate, Hyperkalemia, Hyperparathyroidism, Secondary
- What is being tested?
- Sodium zirconium cyclosilicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2021
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. ESRD MHD with SHPT patients were recruited into this study
Who cannot join
- Patients with severe cardiovascular disease who cannot tolerate general anesthesia surgery were not included in this study.
About this study
Official title: Effect of Sodium Zirconium Cyclosilicate on Hyperkalemia After Parathyroidectomy in Secondary Hyperparathyroidism Patients With Maintenance Hemodialysis
Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients.
However, the effects of SZC during the perioperative period remained unknown.
This experiment aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).
Read the detailed description
Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. SHPT is characterized by elevated parathyroid hormone (PTH) synthesis and secretion accompanied by parathyroid cell hyperplasia.Elevated PTH level is considered as a risk factor for fracture, hyperphosphatemia, anemia, and cardiovascular calcification that worsens the health-related quality of life and increases mortality.
Parathyroidectomy (PTX) has been considered the first-line treatment for severe SHPT. Generally, approximately 29% of patients with end-stage renal disease undergo parathyroidectomy to control secondary hyperparathyroidism. Successful PTX may rapidly reduce serum PTH levels and alleviate clinical symptoms.
Postoperative hyperkalemia is one common complication after PTX. With an incidence of 25-80%, in previous research, hyperkalemia has been reported during and immediately after PTX, leading to devastating consequences.
SZC increases fecal potassium excretion and lowers serum potassium levels by binding potassium ions, demonstrated to reduce serum potassium to normal levels within 48 hours in hyperkalemia patients.
Nevertheless, the effects of SZC during the perioperative period remained unknown.
Sixty-two patients with secondary hyperparathyroidism (SHPT) were randomly recruited into the experimental and control groups. Patients in the experimental group were required to take SZC 10g before PTX. Laboratory chemistries, including serum potassium levels, serum calcium levels and serum PTH were obtained before and after surgery. We aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).
- Being tested
- Sodium zirconium cyclosilicate
- Medical subject headings
- Hyperkalemia, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium zirconium cyclosilicateDrug
The experimental group was required to take SZC 10g at 6 am on the day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group was required to take SZC 10g at 6 am on the day of surgery. Receives: Drug: Sodium zirconium cyclosilicate |
| Control Group | No intervention | No additional intervention was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum potassium levels
Laboratory chemistry measurement
Measured: Serum potassium levels were checked at three time points, which were t0 (6 am on the day of surgery), t1 (immediate after surgery), and t2 (9 pm on the day of surgery), respectively.
Secondary outcomes (1)
Change of serum calcium levels
Laboratory chemistry measurement
Measured: Serum calcium levels were checked at three time points, which were t0 (6 am on the day of surgery), t1 (immediate after surgery), and t2 (9 pm on the day of surgery), respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study startNov 2016
- Primary completionDec 2021
- Study completionDec 2021
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 Sodium Zirconium CyclosilicateStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients had dialysis within 24h before PTX, then were treated with PTX in Otolaryngology Head and Neck Surgery department in Guangdong Provincial People's Hospital by one experienced surgeon. The experimental group was required to take SZC 10g immediately after the blood test at 6 am, while no medical treatment was performed on patients in the control group.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuangxin Liu, Ph.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382988
- Sponsor's protocol ID
- SZC AFTER PTX
- Acronym
- SZC
- Status last verified
- Apr 2022
- First submitted
- 9 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang J, Li S, Su J, Xiao Z, Zhang S, Liu S, Ge P. Effect of sodium zirconium cyclosilicate on hyperkalemia after parathyroidectomy in secondary hyperparathyroidism patients with maintenance hemodialysis: A randomized trial. Medicine (Baltimore). 2024 Dec 27;103(52):e40917. doi: 10.1097/MD.0000000000040917.
PubMed 39969301
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Zirconium Cyclosilicate on Hyperkalemia After Parathyroidectomy in Secondary Hyperparathyroidism Patients With Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT05382988
- Acronym / sponsor ID
- SZC / SZC AFTER PTX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 19 May 2022 (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.
Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients.
However, the effects of SZC during the perioperative period remained unknown.
This experiment aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).
Detailed description
Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. SHPT is characterized by elevated parathyroid hormone (PTH) synthesis and secretion accompanied by parathyroid cell hyperplasia.Elevated PTH level is considered as a risk factor for fracture, hyperphosphatemia, anemia, and cardiovascular calcification that worsens the health-related quality of life and increases mortality.
Parathyroidectomy (PTX) has been considered the first-line treatment for severe SHPT. Generally, approximately 29% of patients with end-stage renal disease undergo parathyroidectomy to control secondary hyperparathyroidism. Successful PTX may rapidly reduce serum PTH levels and alleviate clinical symptoms.
Postoperative hyperkalemia is one common complication after PTX. With an incidence of 25-80%, in previous research, hyperkalemia has been reported during and immediately after PTX, leading to devastating consequences.
SZC increases fecal potassium excretion and lowers serum potassium levels by binding potassium ions, demonstrated to reduce serum potassium to normal levels within 48 hours in hyperkalemia patients.
Nevertheless, the effects of SZC during the perioperative period remained unknown.
Sixty-two patients with secondary hyperparathyroidism (SHPT) were randomly recruited into the experimental and control groups. Patients in the experimental group were required to take SZC 10g before PTX. Laboratory chemistries, including serum potassium levels, serum calcium levels and serum PTH were obtained before and after surgery. We aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients had dialysis within 24h before PTX, then were treated with PTX in Otolaryngology Head and Neck Surgery department in Guangdong Provincial People's Hospital by one experienced surgeon. The experimental group was required to take SZC 10g immediately after the blood test at 6 am, while no medical treatment was performed on patients in the control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Sodium zirconium cyclosilicateThe experimental group was required to take SZC 10g at 6 am on the day of surgery. |
| Control Group | No intervention | –No additional intervention was performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. ESRD MHD with SHPT patients were recruited into this study
Key exclusion criteria (1 listed)
- Patients with severe cardiovascular disease who cannot tolerate general anesthesia surgery were not included in this study.
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 |
|---|---|---|
| Sodium zirconium cyclosilicateThe experimental group was required to take SZC 10g at 6 am on the day of surgery. | Drug | Experimental Group |
Primary outcome
Change of serum potassium levels
Time frame: Serum potassium levels were checked at three time points, which were t0 (6 am on the day of surgery), t1 (immediate after surgery), and t2 (9 pm on the day of surgery), respectively.
Laboratory chemistry measurement
1 secondary outcome
Change of serum calcium levels
Time frame: Serum calcium levels were checked at three time points, which were t0 (6 am on the day of surgery), t1 (immediate after surgery), and t2 (9 pm on the day of surgery), respectively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 39969301Kang J, Li S, Su J, Xiao Z, Zhang S, Liu S, Ge P. Effect of sodium zirconium cyclosilicate on hyperkalemia after parathyroidectomy in secondary hyperparathyroidism patients with maintenance hemodialysis: A randomized trial. Medicine (Baltimore). 2024 Dec 27;103(52):e40917. doi: 10.1097/MD.0000000000040917.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
Hyperkalaemia
RecruitingPhase 2
Swedish Cardiac And Renal Failure Study-1
HFrEF - Heart Failure With Reduced Ejection Fraction, Chronic Kidney Disease
Active, not recruitingPhase 2
OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure
Heart Failure, Hyperkalemia
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.
Shuangxin Liu, Ph.D principal investigator
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium zirconium cyclosilicate in people with Sodium Zirconium Cyclosilicate and Hyperkalemia, run by Guangdong Provincial People's Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 May 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of serum potassium levels (time frame: Serum potassium levels were checked at three time points, which were t0 (6 am on the day of surgery), t1 (immediate after surgery), and t2 (9 pm on the day of surgery), respectively.). 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 NCT05382988, 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 19 May 2022.