Autosomal Dominant Polycystic Kidney Disease (ADPKD)Phase 3NCT02115659
Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 3 study testing Triptolide-Containing Formulation in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- What is being tested?
- Triptolide-Containing Formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to May 2016
- Phase
- Phase 3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ADPKD patient older then 40 years of age without gender limitation
- Estimated glomerular filtration rate (eGFR) higher than 60 ml/min 1.73m2
- documented kidney volume progression with yearly increasing rate more than 6%
- informed consent
Who cannot join
- Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
- impaired liver function as increased liver enzymes (2-fold above normal values)
- uncontrolled hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) under lipid lowering therapy
- granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
- hepatitis B or C, HIV infection
- malignancy
Show all 9Show fewer
- mental illness that interfere with the patient ability to comply with the protocol
- drug or alcohol abuse
- known hypersensitivity to similar drugs as Triptolide-Containing Formulation
Trial locations and contacts
1 site in 1 country.
Changlin Mei, MD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Changlin Mei, MD, chlmei1954@126.com
Changlin Mei, MD
About this study
Official title: Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. It remains to be shown the effect of triptolide-containing formulation on total kidney volume (TKV) enlargement and renal function protection in ADPKD patients.
Read the detailed description
Randomized Controlled Trial
- Being tested
- Triptolide-Containing Formulation, Placebo
- Keywords
- ADPKD, triptolide
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptolide-Containing FormulationDrug
Also called Triptolide-Containing Formulation plus standard treatment.
Triptolide-Containing Formulation (1mg/kg/d) plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.
PlaceboDrug
Also called Placebo plus standard treatment.
Placebo plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain, etc.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo plus standard treatment. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain. Receives: Drug: Placebo |
| Triptolide-Containing Formulation | Experimental | Triptolide-Containing Formulation (1mg/kg/d) was prescribed; Dosage will be adjusted if necessary according to the adverse events monitoring. Receives: Drug: Triptolide-Containing Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal volume measured by high resolution magnetic resolution imaging
Measured: 2 yrs
Secondary outcomes (2)
Estimated glomerular filtration rate (eGFR)
Measured: 2 yrs
Adverse events.
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei changlin, Shanghai Changzheng Hospital
- Investigators
- Changlin Mei, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115659
- Sponsor's protocol ID
- CZKIPLA-ADPKD-002
- Status last verified
- Apr 2014
- First submitted
- 14 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- ClinicalTrials.gov ID
- NCT02115659
- Acronym / sponsor ID
- CZKIPLA-ADPKD-002
- Keywords
- ADPKD, triptolide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 16 Apr 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.
Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. It remains to be shown the effect of triptolide-containing formulation on total kidney volume (TKV) enlargement and renal function protection in ADPKD patients.
Detailed description
Randomized Controlled Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo plus standard treatment. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain. |
| Triptolide-Containing Formulation | Experimental | Drug: Triptolide-Containing FormulationTriptolide-Containing Formulation (1mg/kg/d) was prescribed; Dosage will be adjusted if necessary according to the adverse events monitoring. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ADPKD patient older then 40 years of age without gender limitation
- Estimated glomerular filtration rate (eGFR) higher than 60 ml/min 1.73m2
- documented kidney volume progression with yearly increasing rate more than 6%
- informed consent
Key exclusion criteria (9 listed)
- Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
- impaired liver function as increased liver enzymes (2-fold above normal values)
- uncontrolled hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) under lipid lowering therapy
- granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
- hepatitis B or C, HIV infection
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 |
|---|---|---|
| Triptolide-Containing FormulationAlso: Triptolide-Containing Formulation plus standard treatment.Triptolide-Containing Formulation (1mg/kg/d) plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain. | Drug | Triptolide-Containing Formulation |
| PlaceboAlso: Placebo plus standard treatment.Placebo plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain, etc. | Drug | Placebo |
Primary outcome
renal volume measured by high resolution magnetic resolution imaging
Time frame: 2 yrs
2 secondary outcomes
Estimated glomerular filtration rate (eGFR)
Time frame: 2 yrs
Adverse events.
Time frame: 2 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
Related trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Active, not recruitingObservational study
Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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.
Changlin Mei, MD contact
Changlin Mei, MD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptolide-Containing Formulation in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Shanghai Changzheng Hospital 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 9 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 17 Apr 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Changlin Mei, MD (chlmei1954@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal volume measured by high resolution magnetic resolution imaging (time frame: 2 yrs). 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 17 Apr 2014.