Kidney DiseasesCKPTNNCT05036850
China Kidney Patient Trials Network
An observational study of Kidney Diseases, run by George (Beijing) Clinical Research Co. Ltd. at 1 site in China.
Trial summary
This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Kidney Diseases
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2021to 28 Feb 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be recruited from units that provide a comprehensive nephrology service
Who may be able to join
- Documented diagnosis of primary kidney disease
- Regular visits (at least 6 monthly) with a physician at a participating site
- eGFR > 15 ml/min/1.73 m2
- ≥ 2 years of age
- Willing and able to sign informed consent
- Willing to be approached about participation in interventional research studies
Who cannot join
- 1. Life-expectancy of less than 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
George Clinical (Beijing)
Beijing, Beijing Municipality, 100125
Shengkun Sun, +(86)10 82800864, CKPTN@georgeclincial.com
About this study
This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China.
- Conditions
- Kidney Diseases
- Keywords
- Chronic Kidney Disease, Diabetic Nephropathy, Hypertensive Kidney Disease, Glomerulonephritis, GN, Focal Segmental Glomerulosclerosis, FSGS, Membranous Nephropathy, Minimal Change Disease, IgA Nephropathy, Glomerulonephritis not otherwise specified
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Diabetic Nephropathies, Hypertensive Nephropathy, Glomerulonephritis, Glomerulosclerosis, Focal Segmental, Glomerulonephritis, Membranous, Nephrosis, Lipoid
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 |
|---|---|---|
| Incident and Prevalent Patients | Incident and prevalent patients diagnosed with a kidney disease at participating centres |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR (estimated Glomerular Filtration Rate)
Routine results
Measured: Collected six monthly, up to 5 years
Albuminuria
Routine results
Measured: Collected six monthly, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start27 Sep 2021
- Primary completion15 Sep 2026 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies 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
- 1,200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- George (Beijing) Clinical Research Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036850
- Sponsor's protocol ID
- CKPTN2019
- Acronym
- CKPTN
- Status last verified
- Mar 2023
- First submitted
- 27 Aug 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The current plan is that only aggregate data will be shared for research purposes. IPD would only be reviewed in incidental findings and only be discussed with the participant in question.
Publications
Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ. 2018 Jun 1;96(6):414-422D. doi: 10.2471/BLT.17.206441. Epub 2018 Apr 20.
PubMed 29904224Tonelli M, Muntner P, Lloyd A, Manns BJ, Klarenbach S, Pannu N, James MT, Hemmelgarn BR; Alberta Kidney Disease Network. Risk of coronary events in people with chronic kidney disease compared with those with diabetes: a population-level cohort study. Lancet. 2012 Sep 1;380(9844):807-14. doi: 10.1016/S0140-6736(12)60572-8. Epub 2012 Jun 19.
PubMed 22717317Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
PubMed 15385656McGrogan A, Franssen CF, de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant. 2011 Feb;26(2):414-30. doi: 10.1093/ndt/gfq665. Epub 2010 Nov 10.
PubMed 21068142Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrol. 2004 Feb;15(2):411-9. doi: 10.1097/01.asn.0000100125.21491.46.
PubMed 14747388Perkovic V, Craig JC, Chailimpamontree W, Fox CS, Garcia-Garcia G, Benghanem Gharbi M, Jardine MJ, Okpechi IG, Pannu N, Stengel B, Tuttle KR, Uhlig K, Levey AS. Action plan for optimizing the design of clinical trials in chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):138-144. doi: 10.1016/j.kisu.2017.07.009. Epub 2017 Sep 20.
PubMed 30675428de Zeeuw D, Heerspink HJL, Jardine M, Perkovic V. Renal trials in diabetes need a platform: time for a global approach? Lancet Diabetes Endocrinol. 2018 May;6(5):356-358. doi: 10.1016/S2213-8587(17)30263-2. Epub 2017 Aug 7. No abstract available.
PubMed 28797748
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Kidney Patient Trials Network
- ClinicalTrials.gov ID
- NCT05036850
- Acronym / sponsor ID
- CKPTN / CKPTN2019
- Conditions
- Kidney Diseases
- Keywords
- Chronic Kidney Disease, Diabetic Nephropathy, Hypertensive Kidney Disease, Glomerulonephritis, GN, Focal Segmental Glomerulosclerosis, FSGS, Membranous Nephropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- George (Beijing) Clinical Research Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 8 Sep 2021 (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.
This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incident and Prevalent Patients | – | –Incident and prevalent patients diagnosed with a kidney disease at participating centres |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from units that provide a comprehensive nephrology service
Key inclusion criteria (6 listed)
- Documented diagnosis of primary kidney disease
- Regular visits (at least 6 monthly) with a physician at a participating site
- eGFR > 15 ml/min/1.73 m2
- ≥ 2 years of age
- Willing and able to sign informed consent
Key exclusion criteria (1 listed)
- 1. Life-expectancy of less than 6 months
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
eGFR (estimated Glomerular Filtration Rate)
Time frame: Collected six monthly, up to 5 years
Routine results
Albuminuria
Time frame: Collected six monthly, up to 5 years
Routine results
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 29904224Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ. 2018 Jun 1;96(6):414-422D. doi: 10.2471/BLT.17.206441. Epub 2018 Apr 20.
- Background: PubMed 22717317Tonelli M, Muntner P, Lloyd A, Manns BJ, Klarenbach S, Pannu N, James MT, Hemmelgarn BR; Alberta Kidney Disease Network. Risk of coronary events in people with chronic kidney disease compared with those with diabetes: a population-level cohort study. Lancet. 2012 Sep 1;380(9844):807-14. doi: 10.1016/S0140-6736(12)60572-8. Epub 2012 Jun 19.
- Background: PubMed 15385656Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
- Background: PubMed 21068142McGrogan A, Franssen CF, de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant. 2011 Feb;26(2):414-30. doi: 10.1093/ndt/gfq665. Epub 2010 Nov 10.
- Background: PubMed 14747388Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrol. 2004 Feb;15(2):411-9. doi: 10.1097/01.asn.0000100125.21491.46.
- Background: PubMed 30675428Perkovic V, Craig JC, Chailimpamontree W, Fox CS, Garcia-Garcia G, Benghanem Gharbi M, Jardine MJ, Okpechi IG, Pannu N, Stengel B, Tuttle KR, Uhlig K, Levey AS. Action plan for optimizing the design of clinical trials in chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):138-144. doi: 10.1016/j.kisu.2017.07.009. Epub 2017 Sep 20.
- Background: PubMed 28797748de Zeeuw D, Heerspink HJL, Jardine M, Perkovic V. Renal trials in diabetes need a platform: time for a global approach? Lancet Diabetes Endocrinol. 2018 May;6(5):356-358. doi: 10.1016/S2213-8587(17)30263-2. Epub 2017 Aug 7. No abstract available.
- Individual participant dataSharing planned: No. The current plan is that only aggregate data will be shared for research purposes. IPD would only be reviewed in incidental findings and only be discussed with the participant in question.
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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.
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 Kidney Diseases, run by George (Beijing) Clinical Research Co. Ltd. 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 6 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: looking for participants now, as of the sponsor's last update on 6 Mar 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FanHan Hsu (+61 2 8052 4300, CKPTN@georgeclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (estimated Glomerular Filtration Rate) (time frame: Collected six monthly, up to 5 years). The study lists 2 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 NCT05036850, which also lists 7 linked publications.
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 6 Mar 2023.