NCT04612595

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 3, 2020

Status Verified

April 1, 2020

Enrollment Period

2.4 years

First QC Date

June 15, 2020

Last Update Submit

November 2, 2020

Conditions

Diabetic Kidney Disease

Keywords

serum urea nitrogen to creatinine ratiodiabetic kidney diseasesurvival

Outcome Measures

Primary Outcomes (3)

  • all-cause death

    according to the criteria of death

    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

    10 years

  • increasing by 50% of the serum creatinine level from baseline

    increasing by 50% of the serum creatinine level from baseline

    10 years

Study Arms (4)

Group A

Group A are males with CKD stage 1-2.

Other: serum urea nitrogen to creatinine ratio

Group B

Group B are males with CKD stage 3-4.

Other: serum urea nitrogen to creatinine ratio

Group C

Group C are females with CKD stage 1-2.

Other: serum urea nitrogen to creatinine ratio

Group D

Group D are females with CKD stage 3-4.

Other: serum urea nitrogen to creatinine ratio

Interventions

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.

Group AGroup BGroup CGroup D

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients were diagnosed with DKD, and CKD stages 1-4.
  • Patients' age was between 18-70 years old. ③Clinical datum were complete.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 28655017BACKGROUND

  • 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. No abstract available.

    PMID: 27579659BACKGROUND

  • 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):544. doi: 10.3390/nu10050544.

    PMID: 29702558BACKGROUND

  • 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.

    PMID: 29340320BACKGROUND

  • 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.

    PMID: 27479196BACKGROUND

  • 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.

    PMID: 20673254BACKGROUND

  • 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. doi: 10.1038/ki.1985.10.

    PMID: 3981873BACKGROUND

  • 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. doi: 10.1001/jama.227.1.41. No abstract available.

    PMID: 4859625BACKGROUND

  • 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.

    PMID: 28766029BACKGROUND

  • 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.

    PMID: 29222381BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Wenjian Wang, PhD

    Guangdong Provincial People's Hospital

    STUDY CHAIR

Central Study Contacts

Wenjian Wang, PhD

CONTACT

0086-020-83827812-61421wwjph@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

November 3, 2020

Study Start

August 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)