Polycystic KidneyNCT00801268
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease
A study testing tripterygium wilfordii and Emodin in people with Polycystic Kidney, run by Zhi-Hong Liu, M.D. at 2 sites in China.
Trial summary
Triptolide has been approve effective in animal model. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Polycystic Kidney
- What is being tested?
- tripterygium wilfordii and Emodin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2008to Nov 2013
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically established ADPKD
- eGFR>30ml/min.
- Chinese nationality
Who cannot join
- Uncontrolled infections
- Non-ADPKD complications
Trial locations and contacts
2 sites in 1 country.
China2 sites
Liu ZH, Yao XD,Chen X,Hu YL
Nanjing, Jiangsu, 210002
Yao Xiaodan
Nanjing, Jiangsu, 210002
About this study
Official title: Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Triptolide has been approve effective in animal model.
Read the detailed description
Randomized
- Conditions
- Polycystic Kidney
- Being tested
- tripterygium wilfordii, Emodin
- Keywords
- polycystic kidney disease, tripterygium wilfordii
- Medical subject headings
- Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tripterygium wilfordiiDrug
TW，60mg/d
EmodinDrug
Also called Frangula emodin,Frangulic acid
100mg/d
| Study group | Role | What they receive |
|---|---|---|
| emodin | Active comparator | Not described Receives: Drug: Emodin |
| Triptolide Woldifii | Experimental | TW60mg/d Receives: Drug: tripterygium wilfordii |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI calculated kidney volume, eGFR
Measured: Every 3-6months
Secondary outcomes (1)
End-stage kidney disease (ESRD)
Measured: every 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: high rate of drop-out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic KidneyStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-Hong Liu, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- Liu Zhihong, Master, Principal investigator, Research Institute of Nephrology, Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801268
- Sponsor's protocol ID
- NJCT-0802
- Status last verified
- Mar 2015
- First submitted
- 25 Nov 2008
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- ClinicalTrials.gov ID
- NCT00801268
- Acronym / sponsor ID
- NJCT-0802
- Conditions
- Polycystic Kidney
- Keywords
- polycystic kidney disease, tripterygium wilfordii
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: high rate of drop-out
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Dec 2008 (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.
Triptolide has been approve effective in animal model.
Detailed description
Randomized
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| emodin | Active comparator | Drug: Emodin |
| Triptolide Woldifii | Experimental | Drug: tripterygium wilfordiiTW60mg/d |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically established ADPKD
- eGFR>30ml/min.
- Chinese nationality
Key exclusion criteria (2 listed)
- Uncontrolled infections
- Non-ADPKD complications
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 |
|---|---|---|
| tripterygium wilfordiiTW，60mg/d | Drug | Triptolide Woldifii |
| EmodinAlso: Frangula emodin,Frangulic acid100mg/d | Drug | emodin |
Primary outcome
MRI calculated kidney volume, eGFR
Time frame: Every 3-6months
1 secondary outcome
End-stage kidney disease (ESRD)
Time frame: every 2months
Results and safety
The study was stopped early (reason given: high rate of drop-out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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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.
Liu Zhihong, Master principal investigator
Research Institute of Nephrology, Jinling Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tripterygium wilfordii and Emodin in people with Polycystic Kidney, run by Zhi-Hong Liu, M.D. at 2 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 30 Mar 2015. 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 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 was stopped early (reason given: high rate of drop-out). Results are not available in the source record.
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?
MRI calculated kidney volume, eGFR (time frame: Every 3-6months). 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 30 Mar 2015.