Early Screening and Diagnosis of CKD

Early Screening and Diagnosis of Chronic Kidney Disease

Chronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in adults in China was 10.8%. Albuminuria measurement and estimating glomerular filtration rate (GFR) are the primary means of screening for CKD in epidemiological investigations. However, there are many important problems to be solved, whether albuminuria test or GFR evaluation. The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months, with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein excretion rate (PER) and 24-hour albumin albumin excretion rate (AER) to compare the effects of different times of screening for CKD and observe the daily physiological variation of ACR, PCR, AER and PER, derive ACR and PCR reference value on the basis of different genders, in order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment of GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP) based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid (DTPA) renal clearance method. Then to develop GFR estimation equation based on the combination of serum creatinine, cystatin C, β2 -microglobulin and BTP applicable in China.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Kidney; Disease (Functional)
• Intervention / Treatment: Radiation: 99mTc-DTPA

Detailed Description

Chronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in adults in China was 10.8%. Awareness of CKD is only 10.04% from a national cross-sectional survey in China. CKD is characterised by decreased estimated glomerular filtration rate (eGFR) and increased albuminuria, present for more than three months, and is associated with adverse outcomes (all-cause mortality, acute kidney injury, and end-stage renal disease), independent of hypertension and diabetes, age, or sex. CKD may carry a coronary heart disease risk similar to that of diabetes. The estimated lifetime risk of CKD stage 3a was more than 50%, lower than that of hypertension (83%-90% for a 55-year-old), but higher than those for diabetes (33%-39%), coronary heart disease (32%-49% for a 40-year-old), and invasive cancer (38%-45%).

Albuminuria measurement and estimating glomerular filtration rate (GFR) are the primary means of screening for CKD in epidemiological investigations. However, there are many important problems to be solved, whether albuminuria test or GFR evaluation. The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months, with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein excretion rate (PER) and 24-hour albumin excretion rate (AER) to compare the effects of different times of screening for CKD and observe the daily physiological variation of ACR, PCR, AER and PER, and repeat test to reduce the physiological variation, and further derive ACR and PCR reference value on the basis of different genders, in order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment of GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP) based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid (DTPA) renal clearance method. Then the investigators aim to develop GFR estimation equation based on the combination of serum creatinine, cystatin C, β2-microglobulin and BTP applicable in China, for early and accurate assessment of GFR in Chinese people, and develop appropriate software to estimating GFR.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Xin Du, MD; Phone Number: 86-025-87726209; Email: duxin168@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital, Nanjing Medical University
      • Contact: Xin Du, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Chinese participants with CKD were selected from Nanjing First Hospital in China. All patients met the diagnostic criteria of CKD according to National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (K/DOQI) clinical practice guidelines.

Description

Inclusion Criteria:

• Health examination population at the department of nephrology
• Chronic kidney disease

Exclusion Criteria:

• Severe heart failure
• Acute renal failure
• Pleural or abdominal effusion
• Serious edema or malnutrition
• Skeletal muscle atrophy
• Amputation
• Ketoacidosis
• Patients who were taking trimethoprim or cimetidine or angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blocker (ARB)
• Patients who had recently received glucocorticoid and hemodialysis therapy
• Female during the menstrual period
• Pregnant woman
• Who unable to sign informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronic kidney disease (CKD); chronic kidney disease (CKD) is defined as abnormalities of kidney structure (markers of kidney damage) or function (decreased GFR by 99mTc-DTPA renal clearance and/or eGFR), present for more than 3 months.	Radiation: 99mTc-DTPA; a 99mTc-DTPA renal dynamic imaging measurement as the reference glomerular filtration rate (rGFR).; Other Names: technetium-99m-labeled diethylenetriaminepentaacetic acid
no CKD; Suspected chronic kidney disease but no chronic kidney disease after screening by abnormalities of kidney structure (markers of kidney damage) or function (decreased GFR by 99mTc-DTPA renal clearance and/or eGFR), present for less than 3 months, or no abnormalities of kidney structure or function.	Radiation: 99mTc-DTPA; a 99mTc-DTPA renal dynamic imaging measurement as the reference glomerular filtration rate (rGFR).; Other Names: technetium-99m-labeled diethylenetriaminepentaacetic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bias of estimated GFR less than 5 ml per minute per 1.73 m2 versus reference GFR	Bias was defined as the median results of differences between estimated GFR and reference GFR (eGFR- rGFR).	1 year
Precision of estimated GFR less than 30 ml per minute per 1.73 m2 versus reference GFR	Precision was defined as the interquartile range (IQR) of the differences between estimated GFR and reference GFR.	1 year
Accuracy of estimated GFR more than 70%	Accuracy was calculated as the proportion of estimated GFR within 30% of reference GFR.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
net reclassification index more than 10%	Net reclassification improvement (NRI) was defined as the sum of those classified upward to higher risk in those with an event plus those classified downward to lower risk in those without an event less the sum of those classified downward to lower risk in those with an event plus those classified to higher risk in those without an event. The event in this study was having a measured GFR that was less than 60 ml per minute per 1.73 m2.	1 year
Composite outcomes of sensitivity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.6, or specificity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.8	Sensitivity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.6, or specificity of a single screen using estimated GFR and/or albuminuria to detect CKD more than 0.8	1 year

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Xin Du, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2009
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimated): July 22, 2016

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: chronic kidney disease; estimated glomerular filtration rate; serum creatinine; serum cystatin C
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Anticoagulants; Antidotes; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Edetic Acid; Pentetic Acid
• Other Study ID Numbers: ES-CKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No