Chronic Kidney Disease-Mineral and Bone DisorderPhase 4NGALNCT05720273
Neutrophil Gelatinase-associated Lipocalin VS Vascular Calcification in Maintenance Hemodialysis Patients
A Phase 4 study testing palicalcitol in people with Chronic Kidney Disease-Mineral and Bone Disorder, run by Xiaoyan Jia at 1 site in China.
Trial summary
The goal of this observational study or clinical trial is to learn about the effect of neutrophil gelatinase-associated lipocalin (NGAL) on vascular calcification in maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease-Mineral and Bone Disorder
- What is being tested?
- palicalcitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Mar 2025
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease (CKD) maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT), iPTH>300pg/ml
- Age 18-65 years old
- Haven't used anti-PTH agents within 3 months
- Signed informed consent
Who cannot join
- Allergic to vitamin D or similar drugs
- Vitamin D poisoning
- Expected survival is less than one year
- Acute inflammations, active liver disease, tumor, hospitalization within 3 months
- Fractures, major trauma or operations within 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Xiaoyan Jia, jiaxiaoyan1982@163.com
About this study
Official title: The Effect of Neutrophil Gelatinase-associated Lipocalin Derived From Osteoblasts and Vascular Smooth Muscle Cells on Vascular Calcification in Chronic Kidney Desease and the Intervention of Paliscalcitol - Clinical Research Section
The goal of this observational study or clinical trial is to learn about the effect of neutrophil gelatinase-associated lipocalin (NGAL) on vascular calcification in maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT). The main question it aims to answer is: the predictive effects of blood NGAL level on the efficacy of palicalcitol in the treatment of SHPT and the adverse reactions of vascular calcification progression. Participants will be treated with palicalcitol, followed up and undergo routine series of Chronic Kidney Disease-Mineral and Bone Disorder associated tests before and after treatment.
Read the detailed description
- Sample size calculation: Because there was no previous study on the change of blood NGAL level in MHD patients with palicalcitol; refer to the NGAL changes before and after parathyroidectomy :N=12 NGAL715.84(578.73, 988.14)ng/mL before and 688.42(660.00, 760.26)ng/mL 4-7 days after surgery (p=0.071, paired T-test). According to the 20% loss rate; The sample size is finally determined to be 80 cases.
- Patients: maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT).
- Palicalcitol injection
- Follow-up The patients are followed up for 1 year.
- Statistical methods All statistical tests are conducted by two-sided test, and the first type of error is 0.05 (α value) to determine the statistical significance of the difference. Quantitative data includ efficacy, laboratory test indicators, such as the number of cases, mean, median, standard deviation and range description. Qualitative data includ comorbidities, described in terms of frequency, composition or percentage. Statistical test: The parameter test method is preferred. If the data distribution differs greatly from the requirements of testing the hypothesis, the non-parameter test method will be used. Patients will be divided into two groups according to circulating NGAL levels before treatment; the clinical characteristics, changes of NGAL level, the efficacy of palicalcitol (changes of iPTH) and the main adverse reactions (increased blood calcium and phosphorus, progress of vascular calcification) are compared between two groups. T test or rank sum test are used for difference test. The correlation between blood NGAL level, VC score and CKD-MBD assay indexes is analyzed by pair-wise correlation and logistic multivariate regression.
- Being tested
- palicalcitol
- Keywords
- Chronic Kidney Disease-Mineral and Bone Disorder, Calcitriol Receptor, Lipocalin-2, Vascular Calcification
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palicalcitolDrug
Also called Calcitriol, Calcimimetics
This study does not interfere with the clinical medication of the researchers, and the usage and dosage of the drugs will be recorded according to the actual use. The recommended starting dose of palicalcitol may be based on body weight, baseline iPTH, or combined with prior medication. Dose adjustment should be determined according to pre-dialysis iPTH, Ca and P. iPTH levels should be maintained at 150-300pg/ml, while Ca and P levels should be closely monitored. If hypercalcemia occurs, the dose should be reduced or medication should be discontinued until these parameters return to normal; Subsequently, the dose of palicalcitol should be restarted at a lower dose. If PTH levels decrease as a result of treatment, the dose of medication may need to be reduced accordingly. The dose adjustment interval is 2-4 weeks, and the dose can be adjusted immediately for safety reasons.
| Study group | Role | What they receive |
|---|---|---|
| Palicalcitol | Experimental | Maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT) treat with palicalcitol Receives: Drug: palicalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline plasma NGAL levels at 12months
Elisa
Measured: 12months
Secondary outcomes (1)
Change from baseline vascular calcification at 12months
Coronary calcification scores (CACS) from serial computed tomographic images with the Agatston method is used to evaluate cardio-vascular calcification, 1 point=130~199HU；2 points=200~299HU；3 points =300~399HU；4 points≥400HU. Abdominal aortic calcification score (AACS) is measured by Kauppila method from lateral dual-energy X-ray absorptiometry spine, 0-3 points. Anterior chest radiographs is used to perform simple calcification scores for aortic arch knob, 0-100%. Higher scores mean a worse outcome.
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease-Mineral and Bone DisorderStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Maintenance hemodialysis patients with secondary hyperparathyroidism
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoyan Jia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoyan Jia, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720273
- Sponsor's protocol ID
- YXLL-KY-2022(066)
- Acronym
- NGAL
- Status last verified
- Mar 2024
- First submitted
- 10 Nov 2022
- Last updated
- 8 Mar 2024
- Results posted
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neutrophil Gelatinase-associated Lipocalin Derived From Osteoblasts and Vascular Smooth Muscle Cells on Vascular Calcification in Chronic Kidney Desease and the Intervention of Paliscalcitol - Clinical Research Section
- ClinicalTrials.gov ID
- NCT05720273
- Acronym / sponsor ID
- NGAL / YXLL-KY-2022(066)
- Keywords
- Chronic Kidney Disease-Mineral and Bone Disorder, Calcitriol Receptor, Lipocalin-2, Vascular Calcification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xiaoyan JiaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 9 Feb 2023 (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.
The goal of this observational study or clinical trial is to learn about the effect of neutrophil gelatinase-associated lipocalin (NGAL) on vascular calcification in maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT). The main question it aims to answer is: the predictive effects of blood NGAL level on the efficacy of palicalcitol in the treatment of SHPT and the adverse reactions of vascular calcification progression. Participants will be treated with palicalcitol, followed up and undergo routine series of Chronic Kidney Disease-Mineral and Bone Disorder associated tests before and after treatment.
Detailed description
- Sample size calculation: Because there was no previous study on the change of blood NGAL level in MHD patients with palicalcitol; refer to the NGAL changes before and after parathyroidectomy :N=12 NGAL715.84(578.73, 988.14)ng/mL before and 688.42(660.00, 760.26)ng/mL 4-7 days after surgery (p=0.071, paired T-test). According to the 20% loss rate; The sample size is finally determined to be 80 cases.
- Patients: maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT).
- Palicalcitol injection
- Follow-up The patients are followed up for 1 year.
- Statistical methods All statistical tests are conducted by two-sided test, and the first type of error is 0.05 (α value) to determine the statistical significance of the difference. Quantitative data includ efficacy, laboratory test indicators, such as the number of cases, mean, median, standard deviation and range description. Qualitative data includ comorbidities, described in terms of frequency, composition or percentage. Statistical test: The parameter test method is preferred. If the data distribution differs greatly from the requirements of testing the hypothesis, the non-parameter test method will be used. Patients will be divided into two groups according to circulating NGAL levels before treatment; the clinical characteristics, changes of NGAL level, the efficacy of palicalcitol (changes of iPTH) and the main adverse reactions (increased blood calcium and phosphorus, progress of vascular calcification) are compared between two groups. T test or rank sum test are used for difference test. The correlation between blood NGAL level, VC score and CKD-MBD assay indexes is analyzed by pair-wise correlation and logistic multivariate regression.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Maintenance hemodialysis patients with secondary hyperparathyroidism
| Arm | Type | Receives |
|---|---|---|
| Palicalcitol | Experimental | Drug: palicalcitolMaintenance hemodialysis patients with secondary hyperparathyroidism (SHPT) treat with palicalcitol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic kidney disease (CKD) maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT), iPTH>300pg/ml
- Age 18-65 years old
- Haven't used anti-PTH agents within 3 months
- Signed informed consent
Key exclusion criteria (5 listed)
- Allergic to vitamin D or similar drugs
- Vitamin D poisoning
- Expected survival is less than one year
- Acute inflammations, active liver disease, tumor, hospitalization within 3 months
- Fractures, major trauma or operations within 3 months.
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 |
|---|---|---|
| palicalcitolAlso: Calcitriol, CalcimimeticsThis study does not interfere with the clinical medication of the researchers, and the usage and dosage of the drugs will be recorded according to the actual use. The recommended starting dose of palicalcitol may be based on body weight, baseline iPTH, or combined with prior medication. Dose adjustment should be determined according to pre-dialysis iPTH, Ca and P. iPTH levels should be maintained at 150-300pg/ml, while Ca and P levels should be closely monitored. If hypercalcemia occurs, the dose should be reduced or medication should be discontinued until these parameters return to normal; Subsequently, the dose of palicalcitol should be restarted at a lower dose. If PTH levels decrease as a result of treatment, the dose of medication may need to be reduced accordingly. The dose adjustment interval is 2-4 weeks, and the dose can be adjusted immediately for safety reasons. | Drug | Palicalcitol |
Primary outcome
Change from Baseline plasma NGAL levels at 12months
Time frame: 12months
Elisa
1 secondary outcome
Change from baseline vascular calcification at 12months
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing palicalcitol in people with Chronic Kidney Disease-Mineral and Bone Disorder, run by Xiaoyan Jia 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 4 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 8 Mar 2024. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Jia (0086-0531-89269002, jiaxiaoyan1982@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline plasma NGAL levels at 12months (time frame: 12months). 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 8 Mar 2024.