Chronic Renal InsufficiencyNCT02147782
Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency
An observational study of Chronic Renal Insufficiency and Renal Osteodystrophy, run by Shanghai University of Traditional Chinese Medicine at 4 sites in China.
Trial summary
Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone loss, which is called renal osteodystrophy. Most of the previous studies focused on bone metabolism of patients in late stage of chronic renal insufficiency, especially those with chronic dialysis. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Insufficiency, Renal Osteodystrophy
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- Oct 2012to Dec 2022
- How long will I take part?
- 1 Day
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Cases groups (CKD-5) are recruited from inpatients and outpatients in the 4 centers. Controls are recruited from community samples and physical examination population.
Who may be able to join
- 20-50 years old
- chronic renal insufficiency (Control: normal kidney function; Case: CKD 1-5)
- be willing to and be able to join in the study and signed informed consent
- have not accepted systematical treatment on bone loss or osteoporosis
Who cannot join
- allergies
- secondary osteoporosis caused by other diseases.
- postmenopausal women
- mental illness or psychosis
- patients with bone fracture and need surgery treatment
- taking any medicine that will affect bone metabolism for a long time and can not stop
- women during pregnant stage and breast-feed stage
- with deformity or disability
Trial locations and contacts
4 sites in 1 country.
China4 sites, 2 recruiting
- Recruiting
Anhui Province Hospital of TCM
Hefei, Anhui, 230031
Shunjin Hu, 0551-62838661
Shunjin Hu
- Suspended
Jiangsu Province Hospital of TCM
Nanjing, Jiangsu
- Recruiting
Longhua hospital affiliated to Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Xiaofeng Li, PhD, 86-21-64395700, lixiaofeng0409@163.com
Xiaofeng Li
- Completed
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages
Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone loss, which is called renal osteodystrophy. Most of the previous studies focused on bone metabolism of patients in late stage of chronic renal insufficiency, especially those with chronic dialysis. In this study, bone metabolism of patients in different stages of chronic renal insufficiency will be observed to reveal the mechanism of development of renal osteodystrophy and provide clues for early intervention on renal osteodystrophy.
Read the detailed description
In this study, patients with chronic renal insufficiency (CKD1-5, defined by glomerular filtration rate，GFR) and healthy people as control will be recruited (50/group, total 300). Blood urea nitrogen, creatinine,lumbar and hip bone mineral density, bone turnover biochemical markers including serum total propeptide of type I procollagen（PINP）, bone alkaline phosphatase（BALP）, bone Gla-protein (BGP) and β-CrOSSlaps（β-CTX）, serum calcium and phosphorus and related regulators including fibroblast growth factor 23 (FGF23), 25-hydroxyl-Vitamin D （25-OH-VitD）, parathyroid hormone（PTH） will be detected. The relationship between kidney function and bone turnover, and the rules throughout the development process of renal osteodystrophy will be analysed.The micro ribonucleotide（miRNA）array will also be performed to screen the biomarkers of renal osteodystrophy in different stage.
- Conditions
- Chronic Renal Insufficiency, Renal Osteodystrophy
- Keywords
- chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | Healthy people from physical examination centers are recruited as controls. | |
| CKD1 | 1. with clinical one or more symptoms and signs of kidney injury listed as below： 1. Urinary albumin ( urinary albumin excretion rate≥30 mg/24 h.albumin-creatinine ratio≥3mg/mmol) 2. urinary sediments abnormality 3. renal tubular lesions 4. renal histological abnormalities 5. abnormal structure showed by imaging 6. history of renal transplantation 2. GFR≥90（ml/min/1.73m²) | |
| CKD2 | with clinical symptoms and signs of kidney injury, and 60<=GFR<=89（ml/min/1.73m²) | |
| CKD3 | with clinical symptoms and signs of kidney injury, and 30<=GFR<=59（ml/min/1.73m²) | |
| CKD4 | with clinical symptoms and signs of kidney injury, and 15<=GFR<=29（ml/min/1.73m²) | |
| CKD5 | with clinical symptoms and signs of kidney injury, and GFR<15（ml/min/1.73m²) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone metabolism (bone mineral density and serum bone turnover biomarkers)
lumbar (L1-4 as well as total) and hip (neck, troch, inter and word's) bone mineral density will be recorded by dual energy X-ray absorptiometry. Serum bone turnover biomarkers including total PINP, BGP, BALP and β-CTx will be detected.
Measured: 1 day after enrollment
Secondary outcomes (3)
Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate）
CKD1-5 will be graded by glomerular filtration rate,and blood creatinine and urea nitrogen will be detected.
Measured: 1 day after enrollment
Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD)
Serum calcium and phosphorus will be detected and the calcium-phosphorus product will be calculated.Factors which are related with calcium and phosphorus including FGF23, PTH and 25-OH-VitD will be detected.
Measured: 1 day after enrollment
MicroRNA array
Blood plasma will be collected for microRNA array analysis to find specific biomarkers for each stage.We will also try to find biomarkers for better definitions of chronic renal insufficiency and renal osteodystrophy.
Measured: 1 day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Provincial Hospital, Huadong Hospital, Longhua Hospital
- Responsible party
- Principal investigator, Bing Shu, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yongjun Wang, Doctor, Principal investigator, Shanhgai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147782
- Sponsor's protocol ID
- Renal Osteodystrophy
- Other IDs
- 1RT1270,2010CB530400
- Status last verified
- Sep 2021
- First submitted
- 13 May 2014
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages
- ClinicalTrials.gov ID
- NCT02147782
- Acronym / sponsor ID
- Renal Osteodystrophy
- Conditions
- Chronic Renal Insufficiency, Renal Osteodystrophy
- Keywords
- chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Anhui Provincial Hospital, Huadong Hospital, Longhua Hospital
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 May 2014 (estimated)
- 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.
Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone loss, which is called renal osteodystrophy. Most of the previous studies focused on bone metabolism of patients in late stage of chronic renal insufficiency, especially those with chronic dialysis. In this study, bone metabolism of patients in different stages of chronic renal insufficiency will be observed to reveal the mechanism of development of renal osteodystrophy and provide clues for early intervention on renal osteodystrophy.
Detailed description
In this study, patients with chronic renal insufficiency (CKD1-5, defined by glomerular filtration rate，GFR) and healthy people as control will be recruited (50/group, total 300). Blood urea nitrogen, creatinine,lumbar and hip bone mineral density, bone turnover biochemical markers including serum total propeptide of type I procollagen（PINP）, bone alkaline phosphatase（BALP）, bone Gla-protein (BGP) and β-CrOSSlaps（β-CTX）, serum calcium and phosphorus and related regulators including fibroblast growth factor 23 (FGF23), 25-hydroxyl-Vitamin D （25-OH-VitD）, parathyroid hormone（PTH） will be detected. The relationship between kidney function and bone turnover, and the rules throughout the development process of renal osteodystrophy will be analysed.The micro ribonucleotide（miRNA）array will also be performed to screen the biomarkers of renal osteodystrophy in different stage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| control | – | –Healthy people from physical examination centers are recruited as controls. |
| CKD1 | – | –1. with clinical one or more symptoms and signs of kidney injury listed as below： 1. Urinary albumin ( urinary albumin excretion rate≥30 mg/24 h.albumin-creatinine ratio≥3mg/mmol) 2. urinary sediments abnormality 3. renal tubular lesions 4. renal histological abnormalities 5. abnormal structure showed by imaging 6. history of renal transplantation 2. GFR≥90（ml/min/1.73m²) |
| CKD2 | – | –with clinical symptoms and signs of kidney injury, and 60<=GFR<=89（ml/min/1.73m²) |
| CKD3 | – | –with clinical symptoms and signs of kidney injury, and 30<=GFR<=59（ml/min/1.73m²) |
| CKD4 | – | –with clinical symptoms and signs of kidney injury, and 15<=GFR<=29（ml/min/1.73m²) |
| CKD5 | – | –with clinical symptoms and signs of kidney injury, and GFR<15（ml/min/1.73m²) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cases groups (CKD-5) are recruited from inpatients and outpatients in the 4 centers. Controls are recruited from community samples and physical examination population.
Key inclusion criteria (4 listed)
- 20-50 years old
- chronic renal insufficiency (Control: normal kidney function; Case: CKD 1-5)
- be willing to and be able to join in the study and signed informed consent
- have not accepted systematical treatment on bone loss or osteoporosis
Key exclusion criteria (8 listed)
- allergies
- secondary osteoporosis caused by other diseases.
- postmenopausal women
- mental illness or psychosis
- patients with bone fracture and need surgery treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
bone metabolism (bone mineral density and serum bone turnover biomarkers)
Time frame: 1 day after enrollment
lumbar (L1-4 as well as total) and hip (neck, troch, inter and word's) bone mineral density will be recorded by dual energy X-ray absorptiometry. Serum bone turnover biomarkers including total PINP, BGP, BALP and β-CTx will be detected.
3 secondary outcomes
Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate）
Time frame: 1 day after enrollment
Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD)
Time frame: 1 day after enrollment
MicroRNA array
Time frame: 1 day after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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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.
Yongjun Wang, Doctor principal investigator
Shanhgai University of TCM
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Insufficiency and Renal Osteodystrophy, run by Shanghai University of Traditional Chinese Medicine at 4 sites 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 4 inclusion and 8 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 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Yongjun Wang, MD,PhD (86-21-64385700, yjwang88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone metabolism (bone mineral density and serum bone turnover biomarkers) (time frame: 1 day after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2021.