IgA NephropathyPhase 3NCT02187900
Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
A Phase 3 study testing Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH) and Mycophenolate mofetil (MMF) in people with IgA Nephropathy, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH) and Mycophenolate mofetil (MMF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Sep 2015
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- urinary protein levels ≥1.0 g/24 h
- estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by the MDRD formula (eGFR=194×age-0.287×serum creatinine
- 1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method, mg/dl))
- peripheral blood white blood cell count ≥3000×109/L
- no other cause for tubulointerstitial lesions
- no history of immunomodulatory agent intake before renal biopsy
- no systemic infection
- age between 16 and 65 years
Who cannot join
- severe infections
Trial locations and contacts
1 site in 1 country.
Youming Peng, M.D contact
China1 site, 1 recruiting
- Recruiting
The second Xiangya Hospital of CSU
Changsha, Hunan, 410011
Liyu He, M.D, 8615802604114, heliyu1124@126.com
Liyu He, M.D
About this study
Official title: Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f
The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.
Read the detailed description
Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deficient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy
- Conditions
- IgA Nephropathy
- Being tested
- Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH), Mycophenolate mofetil (MMF)
- Keywords
- Tripterygium Wilfordii HOOK. f., Mycophenolate mofetil
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)Drug
Also called Multi-glycoside of Tripterygium Wilfordii HOOK. f.
The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
Mycophenolate mofetil (MMF)Drug
Also called Mycophenolate mofetil
Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
| Study group | Role | What they receive |
|---|---|---|
| TWH for the treatment of IgAN | Experimental | Interventions :The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months. Receives: Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH) |
| MMF for IgAN | Active comparator | MMF for the treatment of IgAN for 6 months Receives: Drug: Mycophenolate mofetil (MMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients reaching remission
(i) complete remission was defined as the absence of proteinuria (24-h urine protein < 0.4 g/24 h), serum albumin >35 g/L and Scr < 1.24 mg/ dL; (ii) partial remission was defined as a 24-h urine protein ≤ 3.5 g/24 h and a decline of >50% of the baseline value with an Scr elevation of <15% of the baseline value; (iii) no response was defined as a 24-h urine protein >3.5 g/24h, or a decline < 50% of base- line value or increase and/or an Scr level >50% of the baseline value
Measured: one year
Secondary outcomes (1)
Renal survival
Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youming Peng, Second Xiangya Hospital of Central South University
- Investigators
- Shenghua Zhou, MD, Study director, the second xiangya hospital of CSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187900
- Sponsor's protocol ID
- HNXY201401
- Status last verified
- Jul 2014
- First submitted
- 22 Jun 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f
- ClinicalTrials.gov ID
- NCT02187900
- Acronym / sponsor ID
- HNXY201401
- Conditions
- IgA Nephropathy
- Keywords
- Tripterygium Wilfordii HOOK. f., Mycophenolate mofetil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 11 Jul 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.
The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.
Detailed description
Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deficient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TWH for the treatment of IgAN | Experimental | Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)Interventions :The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months. |
| MMF for IgAN | Active comparator | Drug: Mycophenolate mofetil (MMF)MMF for the treatment of IgAN for 6 months |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- urinary protein levels ≥1.0 g/24 h
- estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by the MDRD formula (eGFR=194×age-0.287×serum creatinine
- 1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method, mg/dl))
- peripheral blood white blood cell count ≥3000×109/L
- no other cause for tubulointerstitial lesions
Key exclusion criteria (1 listed)
- severe infections
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 |
|---|---|---|
| Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)Also: Multi-glycoside of Tripterygium Wilfordii HOOK. f.The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months. | Drug | TWH for the treatment of IgAN |
| Mycophenolate mofetil (MMF)Also: Mycophenolate mofetilMycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months | Drug | MMF for IgAN |
Primary outcome
Number of patients reaching remission
Time frame: one year
(i) complete remission was defined as the absence of proteinuria (24-h urine protein < 0.4 g/24 h), serum albumin >35 g/L and Scr < 1.24 mg/ dL; (ii) partial remission was defined as a 24-h urine protein ≤ 3.5 g/24 h and a decline of >50% of the baseline value with an Scr elevation of <15% of the baseline value; (iii) no response was defined as a 24-h urine protein >3.5 g/24h, or a decline < 50% of base- line value or increase and/or an Scr level >50% of the baseline value
1 secondary outcome
Renal survival
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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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.
Youming Peng, M.D contact
Shenghua Zhou, MD study director
the second xiangya hospital of CSU
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 Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH) and Mycophenolate mofetil (MMF) in people with IgA Nephropathy, run by Second Xiangya Hospital of Central South University 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 8 inclusion and 1 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 11 Jul 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. 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 Youming Peng, M.D (8615802604114), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reaching remission (time frame: one year). 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 11 Jul 2014.