Diabetic NephropathyNCT00518362
To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)
A study testing TW in people with Diabetic Nephropathy, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- TW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Mar 2010
- Phase
- Interventional
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
- Proteinuria > 2.5 g/24 h
- serum creatinine < 3 mg/dl
- age 35-65 years
Who cannot join
- Co-existence of anther chronic glomerular nephritis.
- Severe disfunction of the liver
- White blood cell < 3000/ul
- Severe infection in the past 1 month
- Malignant hypertension which in hard to control
- Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Efficacy and Safety of TW vs Valsartan in the DN
The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).
Read the detailed description
Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some patients still have heavy proteinuria,and then loss their renal function rapidly. So, to reduce the proteinuria of DN is a very important therapy target.
Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.
- Conditions
- Diabetic Nephropathy
- Being tested
- TW
- Keywords
- TW, Valsartan, treatment, diabetic nephropathy, Proteinuria
- Medical subject headings
- Diabetic Nephropathies, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWDrug
TW,120 mg/d
| Study group | Role | What they receive |
|---|---|---|
| immunosuppressor | Experimental | Valsartan,160mg/d,TW 120mg/d Receives: Drug: TW |
What is being measured
The primary outcome is the main question the study is designed to answer.
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy
Measured: 6 months
Secondary outcomes (1)
To investigate the safety and tolerability of TW vs ARB. To access whether TW can delay the progression to ESRD or creatinine-doubling in diabetic nephropathy with heavy proteinuria.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Zhihong Liu, Master, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518362
- Sponsor's protocol ID
- NJCT-0701
- Status last verified
- Apr 2009
- First submitted
- 16 Aug 2007
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ge Y, Xie H, Li S, Jin B, Hou J, Zhang H, Shi M, Liu Z. Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial. J Transl Med. 2013 May 31;11:134. doi: 10.1186/1479-5876-11-134.
PubMed 23725518
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy and Safety of TW vs Valsartan in the DN
- ClinicalTrials.gov ID
- NCT00518362
- Acronym / sponsor ID
- NJCT-0701
- Conditions
- Diabetic Nephropathy
- Keywords
- TW, Valsartan, treatment, diabetic nephropathy, Proteinuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Aug 2007 (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.
The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).
Detailed description
Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some patients still have heavy proteinuria,and then loss their renal function rapidly. So, to reduce the proteinuria of DN is a very important therapy target.
Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immunosuppressor | Experimental | Drug: TWValsartan,160mg/d,TW 120mg/d |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
- Proteinuria > 2.5 g/24 h
- serum creatinine < 3 mg/dl
- age 35-65 years
Key exclusion criteria (6 listed)
- Co-existence of anther chronic glomerular nephritis.
- Severe disfunction of the liver
- White blood cell < 3000/ul
- Severe infection in the past 1 month
- Malignant hypertension which in hard to control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TWTW,120 mg/d | Drug | immunosuppressor |
Primary outcome
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy
Time frame: 6 months
1 secondary outcome
To investigate the safety and tolerability of TW vs ARB. To access whether TW can delay the progression to ESRD or creatinine-doubling in diabetic nephropathy with heavy proteinuria.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
- Derived from this study: PubMed 23725518Ge Y, Xie H, Li S, Jin B, Hou J, Zhang H, Shi M, Liu Z. Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial. J Transl Med. 2013 May 31;11:134. doi: 10.1186/1479-5876-11-134.
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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.
Zhihong Liu, Master principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TW in people with Diabetic Nephropathy, run by Nanjing University School of Medicine at 1 site 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 6 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: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518362, which also lists 1 linked publication.
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 27 May 2010.