HyperphosphatemiaNCT02684643
Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients
A study testing enhanced individualised therapy, non-enhanced individualised therapy and regular intervention in people with Hyperphosphatemia and End-stage Renal Disease, run by Huashan Hospital at 1 site in China.
Trial summary
This study is designed to study and compare the efficacy and cost-effectiveness of individualized phosphate-lowering therapy in comparison with regular guideline-recommended therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperphosphatemia, End-stage Renal Disease
- What is being tested?
- enhanced individualised therapy, non-enhanced individualised therapy and regular intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Apr 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-70 years' old
- dialysis vintage more than 3 months on maintenance hemodialysis patients
- using internal arteriovenous fistula
- S[P] > 1.45 mmol/l, PTH (parathyroid hormone, PTH) < 900 ng/ml
- no residual renal function (RRF)
- stable dietary habit
- clear consciousness and capable of communication
- willingness to give written consent and comply with the study protocol
Who cannot join
- severe infection, anemia (Hb < 60 g/L), hypoproteinemia (Alb < 30 g/L)
- pregnancy, lactating women
- history of severe coexisting diseases such as, but not limited to, chronic liver disease, myocardial infection, cerebrovascular accident, malignant hypertension
- history of malignancy
- participation in other dietary, drug-related, or any other clinical trials within 1 month
- history of complications related to elevated S[P] such as, but not limited to primary hypoparathyroidism, type II vitamin D dependent rickets
Show all 9Show fewer
- history of non-compliance
- intolerance to the individualized therapy
- in use of calcitonin and diphosphonate
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to study and compare the efficacy and cost-effectiveness of individualized phosphate-lowering therapy in comparison with regular guideline-recommended therapy.
Read the detailed description
Hyperphosphatemia in hemodialysis patients has been one of the most difficult conundrums for nephrologist for the past two decades. Elevated phosphate contributes to secondary hyperparathyroidism, elevated FGF23 levels, and vascular calcification, which in turn predispose to mortality in this population. Current guidelines recommend limiting dietary phosphate intake, strengthening dialysis and using phosphate binders as three therapies for treatment of hyperphosphatemia. Yet exact clinical implication remains ambiguous: how intense restricted phosphate intake should be and how dosage of phosphate binders and dialysis should be adjusted accordingly. Thus, treatments of hyperphosphatemia have not been effective enough, but appear to be refractory. In the current study, the investigators designed individualized phosphate-lowering therapy based on each patient's phosphate-clearing ability, in order to observe and compare the efficacy and cost-effectiveness of the individualized therapy and the regular guideline-recommended therapy.
- Conditions
- Hyperphosphatemia, End-stage Renal Disease
- Being tested
- enhanced individualised therapy, non-enhanced individualised therapy, regular intervention
- Keywords
- individualised therapy, hyperphosphatemia, hemodialysis, clinical trials, restricted phosphate diet, phosphate binders
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced individualised therapyOther
additional dialysis dosage, modification of medication and prescribed dietary plan
non-enhanced individualised therapyOther
modified medication, prescribed dietary plan and regular three times/week dialysis dosage
regular interventionOther
Phosphate binders and calcitriol would be prescribed according to the guidelines. Phosphate binders included in the study are calcium acetate, calcium carbonate or sevelamer. Dosage is based on patients serum phosphate and calcium level. Calcitriol prescribed in the study is Rocaltrol and the dosage is based on PTH, serum phosphate and calcium level. Patients' diet habit will not be altered.
| Study group | Role | What they receive |
|---|---|---|
| enhanced individualised therapy | Experimental | Patients' dialysis dosage, medication as well as dietary plan will be modified. Receives: Other: enhanced individualised therapy |
| non-enhanced individualised therapy | Experimental | Patients' medication as well as dietary plan will be modified without alteration of dialysis dosage. Receives: Other: non-enhanced individualised therapy |
| regular intervention | Experimental | Phosphate binders and calcitriol will be prescribed and adjusted without altering patients' diet habit. Receives: Other: regular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphate level at the end of the trial
Measured: 6 weeks
Secondary outcomes (3)
Serum calcium
Measured: 6 weeks
parathyroid hormone
serum iPTH level
Measured: 6 weeks
cost of the therapy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionApr 2017
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 HyperphosphatemiaStudies of the same condition, open and under way.
- More trials run by Huashan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684643
- Sponsor's protocol ID
- KY2015-271
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02684643
- Acronym / sponsor ID
- KY2015-271
- Conditions
- Hyperphosphatemia, End-stage Renal Disease
- Keywords
- individualised therapy, hyperphosphatemia, hemodialysis, clinical trials, restricted phosphate diet, phosphate binders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Feb 2016 (estimated)
- 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.
This study is designed to study and compare the efficacy and cost-effectiveness of individualized phosphate-lowering therapy in comparison with regular guideline-recommended therapy.
Detailed description
Hyperphosphatemia in hemodialysis patients has been one of the most difficult conundrums for nephrologist for the past two decades. Elevated phosphate contributes to secondary hyperparathyroidism, elevated FGF23 levels, and vascular calcification, which in turn predispose to mortality in this population. Current guidelines recommend limiting dietary phosphate intake, strengthening dialysis and using phosphate binders as three therapies for treatment of hyperphosphatemia. Yet exact clinical implication remains ambiguous: how intense restricted phosphate intake should be and how dosage of phosphate binders and dialysis should be adjusted accordingly. Thus, treatments of hyperphosphatemia have not been effective enough, but appear to be refractory. In the current study, the investigators designed individualized phosphate-lowering therapy based on each patient's phosphate-clearing ability, in order to observe and compare the efficacy and cost-effectiveness of the individualized therapy and the regular guideline-recommended therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| enhanced individualised therapy | Experimental | Other: enhanced individualised therapyPatients' dialysis dosage, medication as well as dietary plan will be modified. |
| non-enhanced individualised therapy | Experimental | Other: non-enhanced individualised therapyPatients' medication as well as dietary plan will be modified without alteration of dialysis dosage. |
| regular intervention | Experimental | Other: regular interventionPhosphate binders and calcitriol will be prescribed and adjusted without altering patients' diet habit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged 18-70 years' old
- dialysis vintage more than 3 months on maintenance hemodialysis patients
- using internal arteriovenous fistula
- S[P] > 1.45 mmol/l, PTH (parathyroid hormone, PTH) < 900 ng/ml
- no residual renal function (RRF)
Key exclusion criteria (9 listed)
- severe infection, anemia (Hb < 60 g/L), hypoproteinemia (Alb < 30 g/L)
- pregnancy, lactating women
- history of severe coexisting diseases such as, but not limited to, chronic liver disease, myocardial infection, cerebrovascular accident, malignant hypertension
- history of malignancy
- participation in other dietary, drug-related, or any other clinical trials within 1 month
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 |
|---|---|---|
| enhanced individualised therapyadditional dialysis dosage, modification of medication and prescribed dietary plan | Other | enhanced individualised therapy |
| non-enhanced individualised therapymodified medication, prescribed dietary plan and regular three times/week dialysis dosage | Other | non-enhanced individualised therapy |
| regular interventionPhosphate binders and calcitriol would be prescribed according to the guidelines. Phosphate binders included in the study are calcium acetate, calcium carbonate or sevelamer. Dosage is based on patients serum phosphate and calcium level. Calcitriol prescribed in the study is Rocaltrol and the dosage is based on PTH, serum phosphate and calcium level. Patients' diet habit will not be altered. | Other | regular intervention |
Primary outcome
Serum phosphate level at the end of the trial
Time frame: 6 weeks
3 secondary outcomes
Serum calcium
Time frame: 6 weeks
parathyroid hormone
Time frame: 6 weeks
cost of the therapy
Time frame: 6 weeks
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 26 Feb 2018.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced individualised therapy, non-enhanced individualised therapy and regular intervention in people with Hyperphosphatemia and End-stage Renal Disease, run by Huashan Hospital at 1 site in China.
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 9 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 26 Feb 2018. 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 China. 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.
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?
Serum phosphate level at the end of the trial (time frame: 6 weeks). 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 NCT02684643, 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 26 Feb 2018.