CKDNCT04399915
Effect of Oxalate and Urate Metabolism on CKD Evolution
An observational study of CKD and ESRD, run by The Institute of Nephrology of the Academy of Medical Sciences of Ukraine at 1 site in Ukraine.
Trial summary
The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- CKD, ESRD, Hyperuricemia
- How many people
- 250 participants
- Where
- 1 siteUkraine
- Study dates
- 10 Jan 2019to Dec 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD stage 1-5 patients
Who may be able to join
- age >18 years old,
- CKD stage 1-4,
- the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering therapy for at least past 3 months or:
- dialysis treatment for at least 3 months,
- a stable clinical condition and adequately functioning arteriovenous fistula or peritoneal access,
- a target level of Kt/V (≥ 1.4 for the HD patients and ≥1.7 for the PD patients).
Who cannot join
- hospitalization in the preceding 3 months,
- previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
Natalia Stepanova
Kyiv, 04050
Natalia Stepanova, Dr.Sc., +380442259377, nmstep88@gmail.com
About this study
Official title: Effect of Oxalate and Urate Metabolism on the Evolution of Kidney Disease
The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and mortality.
Read the detailed description
The study protocol is approved by a local Ethics Committee and registered in Domestic Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from all subjects participating in the study.
The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy subjects). Routine biochemical parameters including blood and daily dialysate concentration of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples, as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure in serum, urine and dialysate of peritoneal dialysis patients.
The study will be followed up for 3 years. The primary endpoint is cardiovascular events, secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis dose, and so on. The outcomes will be analyzed using statistical software.
- Conditions
- CKD, ESRD, Hyperuricemia, Oxaluria
- Keywords
- CKD, hemodialysis, peritoneal dialysis, oxalate, uric acid, metabolism, renal survival, cardio-vascular events
- Medical subject headings
- Kidney Failure, Chronic, Hyperuricemia, Hyperoxaluria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxalemia/Hyperuricemia Group | Not described | |
| Hyperoxalemia/Hyperuricemia-free Group | Not described | |
| Healthy Subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Survival for CKD stages 1-3
Measured: 3 years
Secondary outcomes (1)
Cardio-vascular Events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start10 Jan 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Nephrology of the Academy of Medical Sciences of Ukraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399915
- Sponsor's protocol ID
- 0119U000002
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxalate and Urate Metabolism on the Evolution of Kidney Disease
- ClinicalTrials.gov ID
- NCT04399915
- Acronym / sponsor ID
- 0119U000002
- Conditions
- CKD, ESRD, Hyperuricemia, Oxaluria
- Keywords
- CKD, hemodialysis, peritoneal dialysis, oxalate, uric acid, metabolism, renal survival, cardio-vascular events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The Institute of Nephrology of the Academy of Medical Sciences of UkraineUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 May 2020 (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 current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and mortality.
Detailed description
The study protocol is approved by a local Ethics Committee and registered in Domestic Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from all subjects participating in the study.
The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy subjects). Routine biochemical parameters including blood and daily dialysate concentration of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples, as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure in serum, urine and dialysate of peritoneal dialysis patients.
The study will be followed up for 3 years. The primary endpoint is cardiovascular events, secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis dose, and so on. The outcomes will be analyzed using statistical software.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperoxalemia/Hyperuricemia Group | – | – |
| Hyperoxalemia/Hyperuricemia-free Group | – | – |
| Healthy Subjects | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD stage 1-5 patients
Key inclusion criteria (6 listed)
- age >18 years old,
- CKD stage 1-4,
- the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering therapy for at least past 3 months or:
- dialysis treatment for at least 3 months,
- a stable clinical condition and adequately functioning arteriovenous fistula or peritoneal access,
Key exclusion criteria (2 listed)
- hospitalization in the preceding 3 months,
- previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis.
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
Renal Survival for CKD stages 1-3
Time frame: 3 years
1 secondary outcome
Cardio-vascular Events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for CKD
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
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?
An observational study of CKD and ESRD, run by The Institute of Nephrology of the Academy of Medical Sciences of Ukraine at 1 site in Ukraine.
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 6 inclusion and 2 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 22 May 2020. 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 Ukraine. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Survival for CKD stages 1-3 (time frame: 3 years). 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 22 May 2020.