Hemodialysis ComplicationNCT05874557

A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

An observational study of Hemodialysis Complication, run by RenJi Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The goal of this retrospective cohort study is to investigate the effects of compound amino acid capsule on nutrition, calcium and phosphorus metabolism in maintenance hemodialysis(MHD) patients. The main questions it aims to answer are: 1. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hemodialysis Complication
Type of treatment: Pill or oral medicine
How many people: 40 participants
Where: No sites listed yet
Study dates: Jun 2023to Aug 2023
Phase: Observational
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: maintenance hemodialysis patients

Who may be able to join

Patients who received maintenance hemodialysis (≥ 3 months) in Renji Hospital;
Regularly participate in the routine laboratory examination of the hemodialysis center every 3 months;
Inclusion criteria of the treatment group: regular treatment with compound amino acid capsule for 9 months (2 tablets, 3 times a day, orally);
Inclusion criteria of the control group: no compound amino acid capsules or similar nutritional supplement were taken.

Who cannot join

Severe heart failure (NYHA III/IV);
Human immunodeficiency virus positive or is suffering from other serious infectious diseases;
Have a history of malignant tumor;
Women during pregnancy or lactation;
Exclusion criteria for treatment group: previous use of amino acids or compound ketoacid supplement

Trial locations and contacts

No sites are listed yet.

Renhua Lu, Doctor contact

86-13361958582

lurenhua1977@hotmail.com

About this study

Official title: Effects of Compound Amino Acid Capsule on Nutrition, Calcium and Phosphorus Metabolism in Maintenance Hemodialysis Patients

Can compound amino acid capsule improve the nutritional status of MHD patients?
Can compound amino acid capsule help to correct the calcium and phosphorus metabolism imbalance of MHD patients?
Is compound amino acid capsule safe for MHD patients? We will collect the medical history and laboratory data of MHD patients who regularly took compound amino acid capsule for 9 months or did not use the same preparation in previous medical experience. We focus on the difference of serum albumin level between the treatment group and the control group within 9 months, as well as prealbumin, hemoglobin, ferritin, calcium, phosphorus, 1,25-OH 2-D3 and intact parathyroid hormone (iPTH).

Conditions: Hemodialysis Complication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05874557
Study group	Role	What they receive
treatment group		MHD patients who took compound amino acid capsules regularly(2# tid po) for 9 months
control group		MHD patients in the control group are selected by PSM with age, sex, dialysis month, baseline BMI, baseline Kt/V and baseline ultrafiltration volume. And they did not take compound amino acid capsules or similar amino acid nutritional supplement for the same 9 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Serum Albumin at 3 months
Change from baseline serum albumin at 3 months of the treatment group and control group are compared.
Measured: Data of both groups at baseline and 3 months are collected and analyzed.
Change from Baseline Serum Albumin at 6 months
Change from baseline serum albumin at 6 months of the treatment group and control group are compared.
Measured: Data of both groups at baseline and 6 months are collected and analyzed.
Change from Baseline Serum Albumin at 9 months
Change from baseline serum albumin at 9 months of the treatment group and control group are compared.
Measured: Data of both groups at baseline and 9 months are collected and analyzed.

Secondary outcomes (42)

Change from Baseline Prealbumin at 3 months of the treatment group
Within the treatment group, prealbumin at 3 months is compared to baseline. In other words, change from baseline prealbumin at 3 months is compared to 0.
Measured: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Prealbumin at 3 months of the control group
Within the control group, prealbumin at 3 months is compared to baseline. In other words, change from baseline prealbumin at 3 months is compared to 0.
Measured: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Prealbumin at 6 months of the treatment group
Within the treatment group, prealbumin at 6 months is compared to baseline. In other words, change from baseline prealbumin at 6 months is compared to 0.
Measured: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Prealbumin at 6 months of the control group
Within the control group, prealbumin at 6 months is compared to baseline. In other words, change from baseline prealbumin at 6 months is compared to 0.
Measured: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Prealbumin at 9 months of the treatment group
Within the treatment group, prealbumin at 9 months is compared to baseline. In other words, change from baseline prealbumin at 9 months is compared to 0.
Measured: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Prealbumin at 9 months of the control group
Within the control group, prealbumin at 9 months is compared to baseline. In other words, change from baseline prealbumin at 9 months is compared to 0.
Measured: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Hemoglobin at 3 months of the treatment group
Within the treatment group, hemoglobin at 3 months is compared to baseline. In other words, change from baseline hemoglobin at 3 months is compared to 0.
Measured: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Hemoglobin at 3 months of the control group
Within the control group, hemoglobin at 3 months is compared to baseline. In other words, change from baseline hemoglobin at 3 months compared to 0.
Measured: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Hemoglobin at 6 months of the treatment group
Within the treatment group, hemoglobin at 6 months is compared to baseline. In other words, change from baseline hemoglobin at 6 months is compared to 0.
Measured: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Hemoglobin at 6 months of the control group
Within the control group, hemoglobin at 6 months is compared to baseline. In other words, change from baseline hemoglobin at 6 months is compared to 0.
Measured: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Hemoglobin at 9 months of the treatment group
Within the treatment group, hemoglobin at 9 months is compared to baseline. In other words, change from baseline hemoglobin at 9 months is compared to 0.
Measured: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Hemoglobin at 9 months of the control group
Within the control group, hemoglobin at 9 months is compared to baseline. In other words, change from baseline hemoglobin at 9 months is compared to 0.
Measured: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Ferritin at 3 months of the treatment group
Within the treatment group, ferritin at 3 months is compared to baseline. In other words, change from baseline ferritin at 3 months is compared to 0.
Measured: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Ferritin at 3 months of the control group
Within the control group, ferritin at 3 months is compared to baseline. In other words, change from baseline ferritin at 3 months is compared to 0.
Measured: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Ferritin at 6 months of the treatment group
Within the treatment group, ferritin at 6 months is compared to baseline. In other words, change from baseline ferritin at 6 months is compared to 0.
Measured: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Ferritin at 6 months of the control group
Within the control group, ferritin at 6 months is compared to baseline. In other words, change from baseline ferritin at 6 months is compared to 0.
Measured: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Ferritin at 9 months of the treatment group
Within the treatment group, ferritin at 9 months is compared to baseline. In other words, change from baseline ferritin at 9 months is compared to 0.
Measured: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Ferritin at 9 months of the control group
Within the control group, ferritin at 9 months is compared to baseline. In other words, change from baseline ferritin at 9 months is compared to 0.
Measured: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Calcium at 3 months of the treatment group
Within the treatment group, calcium at 3 months is compared to baseline. In other words, change from baseline calcium at 3 months is compared to 0.
Measured: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Calcium at 3 months of the control group
Within the control group, calcium at 3 months is compared to baseline. In other words, change from baseline calcium at 3 months is compared to 0.
Measured: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Calcium at 6 months of the treatment group
Within the treatment group, calcium at 6 months is compared to baseline. In other words, change from baseline calcium at 6 months is compared to 0.
Measured: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Calcium at 6 months of the control group
Within the control group, calcium at 6 months is compared to baseline. In other words, change from baseline calcium at 6 months is compared to 0.
Measured: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Calcium at 9 months of the treatment group
Within the treatment group, calcium at 9 months is compared to baseline. In other words, change from baseline calcium at 9 months is compared to 0.
Measured: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Calcium at 9 months of the control group
Within the control group, calcium at 9 months is compared to baseline. In other words, change from baseline calcium at 9 months is compared to 0.
Measured: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Phosphorus at 3 months of the treatment group
Within the treatment group, phosphorus at 3 months is compared to baseline. In other words, change from baseline phosphorus at 3 months is compared to 0.
Measured: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Phosphorus at 3 months of the control group
Within the control group, phosphorus at 3 months is compared to baseline. In other words, change from baseline phosphorus at 3 months is compared to 0.
Measured: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Phosphorus at 6 months of the treatment group
Within the treatment group, phosphorus at 6 months is compared to baseline. In other words, change from baseline phosphorus at 6 months is compared to 0.
Measured: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Phosphorus at 6 months of the control group
Within the control group, phosphorus at 6 months is compared to baseline. In other words, change from baseline phosphorus at 6 months is compared to 0.
Measured: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Phosphorus at 9 months of the treatment group
Within the treatment group, phosphorus at 9 months is compared to baseline. In other words, change from baseline phosphorus at 9 months is compared to 0.
Measured: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Phosphorus at 9 months of the control group
Within the control group, phosphorus at 9 months is compared to baseline. In other words, change from baseline phosphorus at 9th month is compared to 0.
Measured: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 3 months of the treatment group
Within the treatment group, 1,25-(OH) 2-D3 at 3 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 3 months is compared to 0.
Measured: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 3 months of the control group
Within the control group, 1,25-(OH) 2-D3 at 3 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 3 months is compared to 0.
Measured: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 6 months of the treatment group
Within the treatment group, 1,25-(OH) 2-D3 at 6 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 6 months is compared to 0.
Measured: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 6 months of the control group
Within the control group, 1,25-(OH) 2-D3 at 6 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 6 months is compared to 0.
Measured: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 9 months of the treatment group
Within the treatment group, 1,25-(OH) 2-D3 at 9 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 9 months is compared to 0.
Measured: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 9 months of the control group
Within the control group, 1,25-(OH) 2-D3 at 9 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 9 months is compared to 0.
Measured: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Intact Parathyroid Hormone (iPTH) at 3 months of the treatment group
Within the treatment group, iPTH at 3 months is compared to baseline. In other words, change from baseline iPTH at 3 months is compared to 0.
Measured: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline iPTH at 3 months of the control group
Within the control group, iPTH at 3 months is compared to baseline. In other words, change from baseline iPTH at 3 months is compared to 0.
Measured: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline iPTH at 6 months of the treatment group
Within the treatment group, iPTH at 6 months is compared to baseline. In other words, change from baseline iPTH at 6 months is compared to 0.
Measured: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline iPTH at 6 months of the control group
Within the control group, iPTH at 6 months is compared to baseline. In other words, change from baseline iPTH at 6 months is compared to 0.
Measured: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline iPTH at 9 months of the treatment group
Within the treatment group, iPTH at 9 months is compared to baseline. In other words, change from baseline iPTH at 9 months is compared to 0.
Measured: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline iPTH at 9 months of the control group
Within the control group, iPTH at 9 months is compared to baseline. In other words, change from baseline iPTH at 9 months is compared to 0.
Measured: Data of the control group at baseline and 9 months are collected and analyzed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2023Aug 2023

First posted25 May 2023
Study startJun 2023 (estimated)
Primary completionJul 2023 (estimated)
Study completionAug 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
More trials run by RenJi 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05874557
Sponsor's protocol ID: IIT-2023-0042
Status last verified: May 2023
First submitted: 14 Apr 2023
Last updated: 25 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Renhua Lu, Doctor

86-13361958582

lurenhua1977@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemodialysis Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Compound Amino Acid Capsule on Nutrition, Calcium and Phosphorus Metabolism in Maintenance Hemodialysis Patients
ClinicalTrials.gov ID: NCT05874557
Acronym / sponsor ID: IIT-2023-0042
Conditions: Hemodialysis Complication
Study type: Observational
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: RenJi HospitalUniversity, hospital or other
Study start: Jun 2023 (estimated)
Primary completion: Jul 2023 (estimated)
Study completion: Aug 2023 (estimated)
First posted: 25 May 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.

Can compound amino acid capsule improve the nutritional status of MHD patients?
Can compound amino acid capsule help to correct the calcium and phosphorus metabolism imbalance of MHD patients?
Is compound amino acid capsule safe for MHD patients? We will collect the medical history and laboratory data of MHD patients who regularly took compound amino acid capsule for 9 months or did not use the same preparation in previous medical experience. We focus on the difference of serum albumin level between the treatment group and the control group within 9 months, as well as prealbumin, hemoglobin, ferritin, calcium, phosphorus, 1,25-OH 2-D3 and intact parathyroid hormone (iPTH).

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
treatment group	–	–MHD patients who took compound amino acid capsules regularly(2# tid po) for 9 months
control group	–	–MHD patients in the control group are selected by PSM with age, sex, dialysis month, baseline BMI, baseline Kt/V and baseline ultrafiltration volume. And they did not take compound amino acid capsules or similar amino acid nutritional supplement for the same 9 months.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: maintenance hemodialysis patients

Key inclusion criteria (4 listed)

Patients who received maintenance hemodialysis (≥ 3 months) in Renji Hospital;
Regularly participate in the routine laboratory examination of the hemodialysis center every 3 months;
Inclusion criteria of the treatment group: regular treatment with compound amino acid capsule for 9 months (2 tablets, 3 times a day, orally);
Inclusion criteria of the control group: no compound amino acid capsules or similar nutritional supplement were taken.

Key exclusion criteria (5 listed)

Severe heart failure (NYHA III/IV);
Human immunodeficiency virus positive or is suffering from other serious infectious diseases;
Have a history of malignant tumor;
Women during pregnancy or lactation;
Exclusion criteria for treatment group: previous use of amino acids or compound ketoacid supplement

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change from Baseline Serum Albumin at 3 months
Time frame: Data of both groups at baseline and 3 months are collected and analyzed.
Change from baseline serum albumin at 3 months of the treatment group and control group are compared.
Change from Baseline Serum Albumin at 6 months
Time frame: Data of both groups at baseline and 6 months are collected and analyzed.
Change from baseline serum albumin at 6 months of the treatment group and control group are compared.
Change from Baseline Serum Albumin at 9 months
Time frame: Data of both groups at baseline and 9 months are collected and analyzed.
Change from baseline serum albumin at 9 months of the treatment group and control group are compared.

42 secondary outcomes

Change from Baseline Prealbumin at 3 months of the treatment group
Time frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Prealbumin at 3 months of the control group
Time frame: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Prealbumin at 6 months of the treatment group
Time frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Prealbumin at 6 months of the control group
Time frame: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Prealbumin at 9 months of the treatment group
Time frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Prealbumin at 9 months of the control group
Time frame: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Hemoglobin at 3 months of the treatment group
Time frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Hemoglobin at 3 months of the control group
Time frame: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Hemoglobin at 6 months of the treatment group
Time frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Hemoglobin at 6 months of the control group
Time frame: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Hemoglobin at 9 months of the treatment group
Time frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Hemoglobin at 9 months of the control group
Time frame: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Ferritin at 3 months of the treatment group
Time frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Ferritin at 3 months of the control group
Time frame: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Ferritin at 6 months of the treatment group
Time frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Ferritin at 6 months of the control group
Time frame: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Ferritin at 9 months of the treatment group
Time frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Ferritin at 9 months of the control group
Time frame: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Calcium at 3 months of the treatment group
Time frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Calcium at 3 months of the control group
Time frame: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Calcium at 6 months of the treatment group
Time frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Calcium at 6 months of the control group
Time frame: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Calcium at 9 months of the treatment group
Time frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Calcium at 9 months of the control group
Time frame: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Phosphorus at 3 months of the treatment group
Time frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Phosphorus at 3 months of the control group
Time frame: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Phosphorus at 6 months of the treatment group
Time frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Phosphorus at 6 months of the control group
Time frame: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Phosphorus at 9 months of the treatment group
Time frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Phosphorus at 9 months of the control group
Time frame: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 3 months of the treatment group
Time frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 3 months of the control group
Time frame: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 6 months of the treatment group
Time frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 6 months of the control group
Time frame: Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 9 months of the treatment group
Time frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 9 months of the control group
Time frame: Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Intact Parathyroid Hormone (iPTH) at 3 months of the treatment group
Time frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline iPTH at 3 months of the control group
Time frame: Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline iPTH at 6 months of the treatment group
Time frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline iPTH at 6 months of the control group
Time frame: Data of the control group at baseline and 6 months are collected and analyzed.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.

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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.

Renhua Lu, Doctor contact

86-13361958582

lurenhua1977@hotmail.com

Questions about this trial

What is this clinical trial studying?

An observational study of Hemodialysis Complication, run by RenJi 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 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 25 May 2023. 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.

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 Renhua Lu, Doctor (86-13361958582, lurenhua1977@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Serum Albumin at 3 months (time frame: Data of both groups at baseline and 3 months are collected and analyzed.). 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 NCT05874557.

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 25 May 2023.