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Early Screening and Diagnosis of CKD

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ClinicalTrials.gov Identifier: NCT02841371
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney; Disease (Functional) Chronic Kidney Disease 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Screening and Diagnosis of Chronic Kidney Disease
Actual Study Start Date : August 1, 2009
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: 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 Name: technetium-99m-labeled diethylenetriaminepentaacetic acid




Primary Outcome Measures :
  1. Bias of estimated GFR less than 5 ml per minute per 1.73 m2 versus reference GFR [ Time Frame: 1 year ]
    Bias was defined as the median results of differences between estimated GFR and reference GFR (eGFR- rGFR).

  2. Precision of estimated GFR less than 30 ml per minute per 1.73 m2 versus reference GFR [ Time Frame: 1 year ]
    Precision was defined as the interquartile range (IQR) of the differences between estimated GFR and reference GFR.

  3. Accuracy of estimated GFR more than 70% [ Time Frame: 1 year ]
    Accuracy was calculated as the proportion of estimated GFR within 30% of reference GFR.


Secondary Outcome Measures :
  1. net reclassification index more than 10% [ Time Frame: 1 year ]
    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.

  2. 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 [ Time Frame: 1 year ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841371


Contacts
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Contact: Xin Du, MD 86-025-87726209 duxin168@163.com

Locations
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China, Jiangsu
Nanjing First Hospital, Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Xin Du, MD         
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Principal Investigator: Xin Du Nanjing First Hospital, Nanjing Medical University
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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02841371    
Other Study ID Numbers: ES-CKD
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
estimated glomerular filtration rate
serum creatinine
serum cystatin C
chronic kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Edetic Acid
Pentetic Acid
Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Anticoagulants
Calcium Chelating Agents