Diabetic NephropathiesNCT03201406
Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease
An observational study of Diabetic Nephropathies and Lupus Nephritis, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
During 1993 and 2006, a total of 987 patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital. 404 patients with membranoproliferative glomerulonephritis and mesangioproliferative glomerulonephritis, and patients with secondary glomerulonephritis or other renal pathologies… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Diabetic Nephropathies, Lupus Nephritis, Rapidly Progressive Glomerulonephritis
- How many people
- 837 participants
- Where
- 2 sitesTaiwan
- Study dates
- 20 Jun 2017to 31 Dec 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical Center cases
Who may be able to join
- Patients older than 20 years.
- Patients underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis.
- Patients were classified as CKD stages 3A, 3B, 4 and 5 at the time of entry.
Who cannot join
- Patients younger than 20 years.
- Patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as membranoproliferative glomerulonephritis, mesangioproliferative glomerulonephritis, secondary glomerulonephritis, or other renal pathologies, such as, acute tubular necrosis, and tubulointerstitial nephritis.
- Patients older than 20 years but eGFR ≧ 60 ml/min/1.73 m2 at the time of entry.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
YUNG-MING CHEN, M.D., +886-2-2312-3456 ext. 65993, chenym@ntuh.gov.tw
- Recruiting
Yung-Ming Chen
Taipei, 100
YUNG-MING CHEN, M.D., +886-2-2312-3456 ext. 65993, chenym@ntuh.gov.tw
YUNG-MING CHEN, M.D.
About this study
During 1993 and 2006, a total of 987 patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital. 404 patients with membranoproliferative glomerulonephritis and mesangioproliferative glomerulonephritis, and patients with secondary glomerulonephritis or other renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis, acute tubular necrosis, and tubulointerstitial nephritis will be analyzed. The demographic characteristics and laboratory data of these patients at presentation or before renal biopsy will be recorded. These data included parameters such as age, sex, diabetes, hypertension, immunosuppressants treatment, BUN, serum creatinine, albumin, hemoglobin, total cholesterol, triglycerides, and urine protein. All subjects will be followed until 2015 for occurrence of primary endpoints, including all-cause death or ESRD requiring long-term dialysis or renal transplantation. A total of 433 patients who had been followed for 3 years during 2003 and 2007 will receive regular clinic follow-up. GFR will be estimated according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula: 186 x Scr -1.154 x age -0.203 x 0.742 (if female). CKD stage will be determined as described by the National Kidney Foundation of the United States. At the time of entry, GFRs of 30-59, 29-15 and < 15 ml/min/1.73 m2 for more than 3 months will be classified as CKD stages 3, 4 and 5, respectively. Baseline Data of the 433 patients are used as recorded at the beginning during 2003 and 2007. The observation period of each patient is defined to start immediately after the registered measurement of serum creatinine satisfying the above criteria (designated as the index date) and lasted until ESRD or end of 2015. ESRD is defined as initiation of RRT, i.e. chronic dialysis or renal transplantation.
- Conditions
- Diabetic Nephropathies, Lupus Nephritis, Rapidly Progressive Glomerulonephritis, Chronic Kidney Diseases
- Keywords
- Renal biopsy, Chronic kidney disease,Diabetic nephropathy,Lupus Nephritis
- Medical subject headings
- Diabetic Nephropathies, Lupus Nephritis, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
End Stage Renal Disease
Measured: 21 years
Mortality
Measured: 21 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start20 Jun 2017
- Primary completion31 Oct 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 837 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YUNG-MING CHEN, M.D., Principal investigator, Attending Physician, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan, ROC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201406
- Sponsor's protocol ID
- 201612068RIND
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03201406
- Acronym / sponsor ID
- 201612068RIND
- Conditions
- Diabetic Nephropathies, Lupus Nephritis, Rapidly Progressive Glomerulonephritis, Chronic Kidney Diseases
- Keywords
- Renal biopsy, Chronic kidney disease,Diabetic nephropathy,Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 837 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 28 Jun 2017 (actual)
- 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.
During 1993 and 2006, a total of 987 patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital. 404 patients with membranoproliferative glomerulonephritis and mesangioproliferative glomerulonephritis, and patients with secondary glomerulonephritis or other renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis, acute tubular necrosis, and tubulointerstitial nephritis will be analyzed. The demographic characteristics and laboratory data of these patients at presentation or before renal biopsy will be recorded. These data included parameters such as age, sex, diabetes, hypertension, immunosuppressants treatment, BUN, serum creatinine, albumin, hemoglobin, total cholesterol, triglycerides, and urine protein. All subjects will be followed until 2015 for occurrence of primary endpoints, including all-cause death or ESRD requiring long-term dialysis or renal transplantation. A total of 433 patients who had been followed for 3 years during 2003 and 2007 will receive regular clinic follow-up. GFR will be estimated according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula: 186 x Scr -1.154 x age -0.203 x 0.742 (if female). CKD stage will be determined as described by the National Kidney Foundation of the United States. At the time of entry, GFRs of 30-59, 29-15 and < 15 ml/min/1.73 m2 for more than 3 months will be classified as CKD stages 3, 4 and 5, respectively. Baseline Data of the 433 patients are used as recorded at the beginning during 2003 and 2007. The observation period of each patient is defined to start immediately after the registered measurement of serum creatinine satisfying the above criteria (designated as the index date) and lasted until ESRD or end of 2015. ESRD is defined as initiation of RRT, i.e. chronic dialysis or renal transplantation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Center cases
Key inclusion criteria (3 listed)
- Patients older than 20 years.
- Patients underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis.
- Patients were classified as CKD stages 3A, 3B, 4 and 5 at the time of entry.
Key exclusion criteria (3 listed)
- Patients younger than 20 years.
- Patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as membranoproliferative glomerulonephritis, mesangioproliferative glomerulonephritis, secondary glomerulonephritis, or other renal pathologies, such as, acute tubular necrosis, and tubulointerstitial nephritis.
- Patients older than 20 years but eGFR ≧ 60 ml/min/1.73 m2 at the time of entry.
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
End Stage Renal Disease
Time frame: 21 years
Mortality
Time frame: 21 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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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.
YUNG-MING CHEN, M.D. principal investigator
Attending Physician, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan, ROC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies and Lupus Nephritis, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 3 inclusion and 3 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 YUNG-MING CHEN, M.D. (+886-2-2312-3456 ext. 65993, chenym@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End Stage Renal Disease (time frame: 21 years). The study lists 2 primary outcomes in all. 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 2 Jul 2017.