Diabetic Kidney DiseaseNCT04612595
The Association Between sUCR and the Survival in Patients With DKD
An observational study of Diabetic Kidney Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Research Objective: To evaluate the prognostic value of serum urea nitrogen to creatinine ratio (sUCR) in the progression of DKD. Research Design: This study was designed as a multicenter, retrospective cohort study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- serum urea nitrogen to creatinine ratio
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: DKD was defined as those diagnosed by pathological biopsy, or those with eGFR <60 ml/min per 1.73 m2, or presence of clinically detectable albuminuria over 3 months which is caused by diabetes.
Who may be able to join
- Patients were diagnosed with DKD, and CKD stages 1-4.
- Patients' age was between 18-70 years old. ③Clinical datum were complete.
Who cannot join
- ①Patients were combined with other type of kidney disease; ②Pregnancy women; ③Infection; ④Severe liver disease; ⑤ malignant tumor;⑥Acute heart failure; ⑦Acute cardiovascular and cerebrovascular diseases ⑧gastrointestinal hemorrhage.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wenjian Wang, PhD, 0086-020-83827812-61421, wwjph@126.com
About this study
Official title: The Association Between Serum Urea Nitrogen to Creatinine Ratio and the Survival in Patients With DKD
Research Objective: To evaluate the prognostic value of serum urea nitrogen to creatinine ratio (sUCR) in the progression of DKD.
Research Design: This study was designed as a multicenter, retrospective cohort study. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD.
Read the detailed description
Object and source: Patients diagnosed with DKD who meet the inclusion criteria are enrolled into the study.
Observation index: At baseline and every medical visit, therapeutic relevant information was collected. Data mainly include demographic characteristics(age, gender, place of residence, marriage, education degree), lifestyles(smoking, drinking, exercise), clinical characteristics(body mass index, blood pressure, duration , history of CVD, complications, nutrition situation), laboratory indexes (serum creatinine, blood urea nitrogen, glycosylated hemoglobin, urinary albumin to creatinine ratio, 24-hour urinary albumin, 24-hour urine urea nitrogen, etc.).
Quality assurance plan: The present study should be performed according to the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Guangdong Provincial People's Hospital.
Plan for missing data: When the participants drop out, the researcher should contact the participants by phone, email, text message, letter etc. and ask the reason, making record as full as possible.
Statistical analysis plan: Data are presented as mean±SD for continuous variables and as a number(percentage) for categorical variables. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD. The relationship between baseline characteristics among the four groups was compared by using one-way analysis of variance test, Kruskal-Wallis test or Chi-squared test where appropriate. Survival rates are estimated using Kaplan-Meier analysis, and the significance of differences was analyzed using the log-rank test. Cox proportional hazard regression analysis is used to assess the association between the clinical outcomes and mean sUCR and ΔsUCR. In multivariate analysis, we enter variables using a P value of <0.10 as the selection criterion or considered clinically significant. Hazard ratios (HRs) are presented with 95% CIs. All statistical analysis was performed with the use of SPSS (version 19.0, SPSS, Chicago, USA) and Prism 7.0 (GraphPad Software, San Diego, CA, USA). A two-tailed P value <0.05 was considered to be statistically significant.
- Conditions
- Diabetic Kidney Disease
- Being tested
- serum urea nitrogen to creatinine ratio
- Keywords
- serum urea nitrogen to creatinine ratio, diabetic kidney disease, survival
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum urea nitrogen to creatinine ratioOther
According to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ΔsUCR can influent the survival of DKD patients.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A are males with CKD stage 1-2. Receives: Other: serum urea nitrogen to creatinine ratio | |
| Group B | Group B are males with CKD stage 3-4. Receives: Other: serum urea nitrogen to creatinine ratio | |
| Group C | Group C are females with CKD stage 1-2. Receives: Other: serum urea nitrogen to creatinine ratio | |
| Group D | Group D are females with CKD stage 3-4. Receives: Other: serum urea nitrogen to creatinine ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
according to the criteria of death
Measured: 10 years
a composite of end-stage kidney disease
dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2
Measured: 10 years
increasing by 50% of the serum creatinine level from baseline
increasing by 50% of the serum creatinine level from baseline
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Aug 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjian Wang, PhD, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612595
- Sponsor's protocol ID
- WJWang002
- Status last verified
- Apr 2020
- First submitted
- 15 Jun 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang L, Gao P, Zhang M, Huang Z, Zhang D, Deng Q, Li Y, Zhao Z, Qin X, Jin D, Zhou M, Tang X, Hu Y, Wang L. Prevalence and Ethnic Pattern of Diabetes and Prediabetes in China in 2013. JAMA. 2017 Jun 27;317(24):2515-2523. doi: 10.1001/jama.2017.7596.
PubMed 28655017Zhang L, Long J, Jiang W, Shi Y, He X, Zhou Z, Li Y, Yeung RO, Wang J, Matsushita K, Coresh J, Zhao MH, Wang H. Trends in Chronic Kidney Disease in China. N Engl J Med. 2016 Sep 1;375(9):905-6. doi: 10.1056/NEJMc1602469. No abstract available.
PubMed 27579659Kitada M, Ogura Y, Monno I, Koya D. A Low-Protein Diet for Diabetic Kidney Disease: Its Effect and Molecular Mechanism, an Approach from Animal Studies. Nutrients. 2018 Apr 27;10(5):544. doi: 10.3390/nu10050544.
PubMed 29702558Metzger M, Yuan WL, Haymann JP, Flamant M, Houillier P, Thervet E, Boffa JJ, Vrtovsnik F, Froissart M, Bankir L, Fouque D, Stengel B. Association of a Low-Protein Diet With Slower Progression of CKD. Kidney Int Rep. 2017 Aug 30;3(1):105-114. doi: 10.1016/j.ekir.2017.08.010. eCollection 2018 Jan.
PubMed 29340320Song M, Fung TT, Hu FB, Willett WC, Longo VD, Chan AT, Giovannucci EL. Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality. JAMA Intern Med. 2016 Oct 1;176(10):1453-1463. doi: 10.1001/jamainternmed.2016.4182.
PubMed 27479196Bross R, Noori N, Kovesdy CP, Murali SB, Benner D, Block G, Kopple JD, Kalantar-Zadeh K. Dietary assessment of individuals with chronic kidney disease. Semin Dial. 2010 Jul-Aug;23(4):359-64. doi: 10.1111/j.1525-139X.2010.00743.x. Epub 2010 Jul 29.
PubMed 20673254Maroni BJ, Steinman TI, Mitch WE. A method for estimating nitrogen intake of patients with chronic renal failure. Kidney Int. 1985 Jan;27(1):58-65. doi: 10.1038/ki.1985.10.
PubMed 3981873Kopple JD, Coburn JW. Evaluation of chronic uremia. Importance of serum urea nitrogen, serum creatinine, and their ratio. JAMA. 1974 Jan 7;227(1):41-4. doi: 10.1001/jama.227.1.41. No abstract available.
PubMed 4859625Inaguma D, Koide S, Ito E, Takahashi K, Hayashi H, Hasegawa M, Yuzawa Y; AICOPP group. Ratio of blood urea nitrogen to serum creatinine at initiation of dialysis is associated with mortality: a multicenter prospective cohort study. Clin Exp Nephrol. 2018 Apr;22(2):353-364. doi: 10.1007/s10157-017-1458-x. Epub 2017 Aug 1.
PubMed 28766029American Diabetes Association. 10. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S105-S118. doi: 10.2337/dc18-S010.
PubMed 29222381
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Serum Urea Nitrogen to Creatinine Ratio and the Survival in Patients With DKD
- ClinicalTrials.gov ID
- NCT04612595
- Acronym / sponsor ID
- WJWang002
- Conditions
- Diabetic Kidney Disease
- Keywords
- serum urea nitrogen to creatinine ratio, diabetic kidney disease, survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Nov 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.
Research Objective: To evaluate the prognostic value of serum urea nitrogen to creatinine ratio (sUCR) in the progression of DKD.
Research Design: This study was designed as a multicenter, retrospective cohort study. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD.
Detailed description
Object and source: Patients diagnosed with DKD who meet the inclusion criteria are enrolled into the study.
Observation index: At baseline and every medical visit, therapeutic relevant information was collected. Data mainly include demographic characteristics(age, gender, place of residence, marriage, education degree), lifestyles(smoking, drinking, exercise), clinical characteristics(body mass index, blood pressure, duration , history of CVD, complications, nutrition situation), laboratory indexes (serum creatinine, blood urea nitrogen, glycosylated hemoglobin, urinary albumin to creatinine ratio, 24-hour urinary albumin, 24-hour urine urea nitrogen, etc.).
Quality assurance plan: The present study should be performed according to the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Guangdong Provincial People's Hospital.
Plan for missing data: When the participants drop out, the researcher should contact the participants by phone, email, text message, letter etc. and ask the reason, making record as full as possible.
Statistical analysis plan: Data are presented as mean±SD for continuous variables and as a number(percentage) for categorical variables. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD. The relationship between baseline characteristics among the four groups was compared by using one-way analysis of variance test, Kruskal-Wallis test or Chi-squared test where appropriate. Survival rates are estimated using Kaplan-Meier analysis, and the significance of differences was analyzed using the log-rank test. Cox proportional hazard regression analysis is used to assess the association between the clinical outcomes and mean sUCR and ΔsUCR. In multivariate analysis, we enter variables using a P value of <0.10 as the selection criterion or considered clinically significant. Hazard ratios (HRs) are presented with 95% CIs. All statistical analysis was performed with the use of SPSS (version 19.0, SPSS, Chicago, USA) and Prism 7.0 (GraphPad Software, San Diego, CA, USA). A two-tailed P value <0.05 was considered to be statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: serum urea nitrogen to creatinine ratioGroup A are males with CKD stage 1-2. |
| Group B | – | Other: serum urea nitrogen to creatinine ratioGroup B are males with CKD stage 3-4. |
| Group C | – | Other: serum urea nitrogen to creatinine ratioGroup C are females with CKD stage 1-2. |
| Group D | – | Other: serum urea nitrogen to creatinine ratioGroup D are females with CKD stage 3-4. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DKD was defined as those diagnosed by pathological biopsy, or those with eGFR <60 ml/min per 1.73 m2, or presence of clinically detectable albuminuria over 3 months which is caused by diabetes.
Key inclusion criteria (2 listed)
- Patients were diagnosed with DKD, and CKD stages 1-4.
Key exclusion criteria (1 listed)
- ①Patients were combined with other type of kidney disease; ②Pregnancy women; ③Infection; ④Severe liver disease; ⑤ malignant tumor;⑥Acute heart failure; ⑦Acute cardiovascular and cerebrovascular diseases ⑧gastrointestinal hemorrhage.
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 |
|---|---|---|
| serum urea nitrogen to creatinine ratioAccording to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ΔsUCR can influent the survival of DKD patients. | Other | Group A, Group B, Group C, Group D |
Primary outcome
all-cause death
Time frame: 10 years
according to the criteria of death
a composite of end-stage kidney disease
Time frame: 10 years
dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2
increasing by 50% of the serum creatinine level from baseline
Time frame: 10 years
increasing by 50% of the serum creatinine level from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 28655017Wang L, Gao P, Zhang M, Huang Z, Zhang D, Deng Q, Li Y, Zhao Z, Qin X, Jin D, Zhou M, Tang X, Hu Y, Wang L. Prevalence and Ethnic Pattern of Diabetes and Prediabetes in China in 2013. JAMA. 2017 Jun 27;317(24):2515-2523. doi: 10.1001/jama.2017.7596.
- Background: PubMed 27579659Zhang L, Long J, Jiang W, Shi Y, He X, Zhou Z, Li Y, Yeung RO, Wang J, Matsushita K, Coresh J, Zhao MH, Wang H. Trends in Chronic Kidney Disease in China. N Engl J Med. 2016 Sep 1;375(9):905-6. doi: 10.1056/NEJMc1602469. No abstract available.
- Background: PubMed 29702558Kitada M, Ogura Y, Monno I, Koya D. A Low-Protein Diet for Diabetic Kidney Disease: Its Effect and Molecular Mechanism, an Approach from Animal Studies. Nutrients. 2018 Apr 27;10(5):544. doi: 10.3390/nu10050544.
- Background: PubMed 29340320Metzger M, Yuan WL, Haymann JP, Flamant M, Houillier P, Thervet E, Boffa JJ, Vrtovsnik F, Froissart M, Bankir L, Fouque D, Stengel B. Association of a Low-Protein Diet With Slower Progression of CKD. Kidney Int Rep. 2017 Aug 30;3(1):105-114. doi: 10.1016/j.ekir.2017.08.010. eCollection 2018 Jan.
- Background: PubMed 27479196Song M, Fung TT, Hu FB, Willett WC, Longo VD, Chan AT, Giovannucci EL. Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality. JAMA Intern Med. 2016 Oct 1;176(10):1453-1463. doi: 10.1001/jamainternmed.2016.4182.
- Background: PubMed 20673254Bross R, Noori N, Kovesdy CP, Murali SB, Benner D, Block G, Kopple JD, Kalantar-Zadeh K. Dietary assessment of individuals with chronic kidney disease. Semin Dial. 2010 Jul-Aug;23(4):359-64. doi: 10.1111/j.1525-139X.2010.00743.x. Epub 2010 Jul 29.
- Background: PubMed 3981873Maroni BJ, Steinman TI, Mitch WE. A method for estimating nitrogen intake of patients with chronic renal failure. Kidney Int. 1985 Jan;27(1):58-65. doi: 10.1038/ki.1985.10.
- Background: PubMed 4859625Kopple JD, Coburn JW. Evaluation of chronic uremia. Importance of serum urea nitrogen, serum creatinine, and their ratio. JAMA. 1974 Jan 7;227(1):41-4. doi: 10.1001/jama.227.1.41. No abstract available.
- Background: PubMed 28766029Inaguma D, Koide S, Ito E, Takahashi K, Hayashi H, Hasegawa M, Yuzawa Y; AICOPP group. Ratio of blood urea nitrogen to serum creatinine at initiation of dialysis is associated with mortality: a multicenter prospective cohort study. Clin Exp Nephrol. 2018 Apr;22(2):353-364. doi: 10.1007/s10157-017-1458-x. Epub 2017 Aug 1.
- Background: PubMed 29222381American Diabetes Association. 10. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S105-S118. doi: 10.2337/dc18-S010.
- 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.
Wenjian Wang, PhD study chair
Guangdong Provincial People's Hospital
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 Diabetic Kidney Disease, run by Guangdong Provincial People's Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 3 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjian Wang, PhD (0086-020-83827812-61421, wwjph@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death (time frame: 10 years). 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 NCT04612595, which also lists 10 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 3 Nov 2020.