The Association Between sUCR and the Survival in Patients With DKD

Diabetic Kidney Disease Clinical Trial

Official title:

The Association Between Serum Urea Nitrogen to Creatinine Ratio and the Survival in Patients With DKD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612595
• Other study ID #: WJWang002
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Guangdong Provincial People's Hospital
• Contact: Wenjian Wang, PhD
• Phone: 0086-020-83827812-61421
• Email: wwjph[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Patients were diagnosed with DKD, and CKD stages 1-4.

• Patients' age was between 18-70 years old. ?Clinical datum were complete.

Exclusion criteria:

?Patients were combined with other type of kidney disease; ?Pregnancy women; ?Infection; ?Severe liver disease; ? malignant tumor;?Acute heart failure; ?Acute cardiovascular and cerebrovascular diseases ?gastrointestinal hemorrhage.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Other:
• serum urea nitrogen to creatinine ratio
According to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ?sUCR can influent the survival of DKD patients.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

American 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. Review. — View Citation

Bross 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. Review. — View Citation

Inaguma 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. — View Citation

Kitada 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). pii: E544. doi: 10.3390/nu10050544. Review. — View Citation

Kopple 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. — View Citation

Maroni 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. — View Citation

Metzger 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. — View Citation

Song 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. Erratum in: JAMA Intern Med. 2016 Nov 1;176(11):1728. — View Citation

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. — View Citation

Zhang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause death	according to the criteria of death	10 years
Primary	a composite of end-stage kidney disease	dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2	10 years
Primary	increasing by 50% of the serum creatinine level from baseline	increasing by 50% of the serum creatinine level from baseline	10 years