Chronic Kidney Disease (Stages 3b-5)NCT07272733
Early Detection, Remote Augmented Reality Combined Rehabilitation Therapy, and Translational Therapy for Patients With Chronic Kidney Disease and Cognitive Disorder
An observational study of Chronic Kidney Disease (Stages 3b-5) and Mild Cognitive Disorder, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
More than half of the patients with nephropathy have cognitive impairment, which can reach the level of dementia.The decline of renal function is more serious. With the aging of the population and changes in lifestyle, the number of patients is increasing day by day. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Kidney Disease (Stages 3b-5), Mild Cognitive Disorder
- What is being tested?
- Ketosteril
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2022to 6 Feb 2025
- How long will I take part?
- 6 Months
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic kidney disease
Who may be able to join
- Chronic kidney disease stage 3-5
Who cannot join
- without cognitive disorder
Trial locations and contacts
1 site in 1 country.
About this study
More than half of the patients with nephropathy have cognitive impairment, which can reach the level of dementia.The decline of renal function is more serious. With the aging of the population and changes in lifestyle, the number of patients is increasing day by day. The reasons are 1.Chronic kidney disease is prone to sarcopenia due to restricted protein intake, and even affects the heart and brain other than the kidneys. 2. Often accompanied by limb weakness and inconvenience of movement, sometimes it is very inconvenient to go to the hospital for treatment, so the hospital is the center cardio to perform telerehabilitation therapy is another option, so the purpose of this study is for patients with cognitive impairment Rehabilitation in virtual reality at a distance to evaluate its effectiveness. In this study, we selected from the treatment room of Beijing Medical Rehabilitation Department choose a space, simulate the situation of home telerehabilitation, and implement virtual reality telerehabilitation with the hospital as the center. The effect of distance rehabilitation and traditional rehabilitation. The study is expected to recruit 60 patients with chronic cognitive impairment and kidney disease who will be randomized. Divided into two groups A, B and C for training, 20 patients in each group, of which group A received ketoacid amino acid supplementation therapy, 3 capsules per day for 3 months; patients in group B received telerehabilitation for 30 minutes three days a week for a total of 3 months; C C The group was the control group, and the treatment was carried out according to the medical routine. The 60 patients received cognitive function,Brain functional MRI, balance ability, clinical function, clinical physical data, daily living function and depression Index evaluation. The results of this study can be used as a reference for future home tele-rehabilitation and ketoacid amino acid supplementation.
- Being tested
- Ketosteril
- Medical subject headings
- Renal Insufficiency, Chronic, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetosterilDrug
Ketosteril will lower protein binded uremic toxin
| Study group | Role | What they receive |
|---|---|---|
| CKD stage 3-5 Age between 20-85 with mild cognitive disorder | Not described Receives: Drug: Ketosteril |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Cognitive test
Measured: Half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Sep 2022
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
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 Chronic Kidney Disease (Stages 3b-5)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272733
- Sponsor's protocol ID
- N202208048
- Other IDs
- NSTC 112-2221-E-038-016
- Status last verified
- Oct 2023
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng TW, Hsieh KL, Kao CC, Lee HH, Lin YC, Lai CH. Associations Between Renal Function, Uremic Toxins, and Cognitive Performance in Patients with Chronic Kidney Disease: A Pilot Study. Int J Med Sci. 2026 Jul 30;23(9):2899-2910. doi: 10.7150/ijms.133922. eCollection 2026.
PubMed 42694884
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection, Remote Augmented Reality Combined Rehabilitation Therapy, and Translational Therapy for Patients With Chronic Kidney Disease and Cognitive Disorder
- ClinicalTrials.gov ID
- NCT07272733
- Acronym / sponsor ID
- N202208048
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 9 Dec 2025 (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.
More than half of the patients with nephropathy have cognitive impairment, which can reach the level of dementia.The decline of renal function is more serious. With the aging of the population and changes in lifestyle, the number of patients is increasing day by day. The reasons are 1.Chronic kidney disease is prone to sarcopenia due to restricted protein intake, and even affects the heart and brain other than the kidneys. 2. Often accompanied by limb weakness and inconvenience of movement, sometimes it is very inconvenient to go to the hospital for treatment, so the hospital is the center cardio to perform telerehabilitation therapy is another option, so the purpose of this study is for patients with cognitive impairment Rehabilitation in virtual reality at a distance to evaluate its effectiveness. In this study, we selected from the treatment room of Beijing Medical Rehabilitation Department choose a space, simulate the situation of home telerehabilitation, and implement virtual reality telerehabilitation with the hospital as the center. The effect of distance rehabilitation and traditional rehabilitation. The study is expected to recruit 60 patients with chronic cognitive impairment and kidney disease who will be randomized. Divided into two groups A, B and C for training, 20 patients in each group, of which group A received ketoacid amino acid supplementation therapy, 3 capsules per day for 3 months; patients in group B received telerehabilitation for 30 minutes three days a week for a total of 3 months; C C The group was the control group, and the treatment was carried out according to the medical routine. The 60 patients received cognitive function,Brain functional MRI, balance ability, clinical function, clinical physical data, daily living function and depression Index evaluation. The results of this study can be used as a reference for future home tele-rehabilitation and ketoacid amino acid supplementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD stage 3-5 Age between 20-85 with mild cognitive disorder | – | Drug: Ketosteril |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic kidney disease
Key inclusion criteria (1 listed)
- Chronic kidney disease stage 3-5
Key exclusion criteria (1 listed)
- without cognitive disorder
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 |
|---|---|---|
| KetosterilKetosteril will lower protein binded uremic toxin | Drug | CKD stage 3-5 Age between 20-85 with mild cognitive disorder |
Primary outcome
MMSE
Time frame: Half a year
Cognitive test
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 9 Dec 2025.
- Derived from this study: PubMed 42694884Cheng TW, Hsieh KL, Kao CC, Lee HH, Lin YC, Lai CH. Associations Between Renal Function, Uremic Toxins, and Cognitive Performance in Patients with Chronic Kidney Disease: A Pilot Study. Int J Med Sci. 2026 Jul 30;23(9):2899-2910. doi: 10.7150/ijms.133922. eCollection 2026.
- 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.
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?
An observational study of Chronic Kidney Disease (Stages 3b-5) and Mild Cognitive Disorder, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 9 Dec 2025. 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 Taiwan. 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?
MMSE (time frame: Half a year). 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 NCT07272733, 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 9 Dec 2025.