Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisNCT02294344
The Clinical Efficacy of DFPP in Patients With AAGN
A study testing DFPP&CTX and CTX in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, run by Zhi-Hong Liu, M.D. at 1 site in China.
Trial summary
The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- What is being tested?
- DFPP&CTX and CTX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Apr 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of ANCA associated vasculitis(AAV), using criteria adapted from the disease definitions of the Chapel Hill consensus conference
- serum positive ANCA and the ANCA level ≥100 relative unit/ml
- with renal involvement and serum creatinine≥3 mg/dl
- written informed consent had been provided.
Who cannot join
- other secondary vasculitis
- anti-glomerular basement membrane(GBM) positive
- severe infection; hepatitis B antigenemia, anti- hepatitis C virus
- immunodeficiency; or immunoglobulin G(IgG)<2g/l
- life threatening
- renal biopsy show globally sclerotic glomeruli>60% and normal glomeruli<10%
- need renal replacement therapy for more than 4w
- received large dose of methylprednisolone(MP),CTX,mycophenolate mofetil(MMF), plasmapheresis or intravenous immunoglobulin(IVIg) therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002
About this study
Official title: A Prospective, Controlled Study of Double Filtration Plasmapheresis (DFPP) in Patients With Antineutrophil Cytoplasmic Autoantibody Associated Glomerulonephritis (AAGN)
The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
Read the detailed description
This is a single center, prospective, randomized,controlled study to compare the clinical efficacy of double filtration plasmapheresis (DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy versus IV-CTX pulse therapy in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
- Being tested
- DFPP&CTX, CTX
- Keywords
- double filtration plasmapheresis, ANCA-Associated Vasculitis
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFPP&CTXOther
Also called Double Filtration Plasmapheresis +cyclophosphamide
First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy.
Then double volume of plasma was processed during each DFPP session every two day. A fraction plasma separator(Asahi Kasei Medical, surface area 2.0 m2,pore size 0.03 mm)and another fraction plasma separator (Asahi Kasei Medical, surface area 2.0 m2, pore size 0.01 mm)were used as first and second filter for plasma fractionation, respectively. 1.5 volume of plasma was processed, and 35~45g human albumin and blood plasma was supplemented during each session. The patients were treated with DFPP every two days for at least 3 times. After DFPP, 300-500ml blood plasma was supplemented.
CTXDrug
Also called cyclophosphamide
First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy.
After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study. The other patients after CTX pulse therapy for 6 months and achieve remission to receive oral maintenance therapy with azathioprine (AZA).
The dosage of AZA was 1.0-2.0mg/kg/d(more than 50mg/d) and adjusted by white cell count and liver enzyme. If white cell count <3×109/L or an increase in liver enzyme to more than twice the normal upper limit, the dosage of AZA should be reduced. If white cell count <3×109/L or liver enzyme increased repeatedly, the patient would be withdrawn from the study.
| Study group | Role | What they receive |
|---|---|---|
| DFPP&CTX | Experimental | double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP\&CTX) Receives: Other: DFPP&CTX |
| cyclophosphamide | Active comparator | cyclophosphamide(CTX) pulse therapy Receives: Drug: CTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
the renal recovery rate
the renal recovery rate at 3 mo defined by dialysis independence and the SCr <5mg/dl for the patients needed renal replacement therapy at the basement, or the SCr decreased more than 30% of the baseline and the urine sediment red blood cell less than 50*104/ml for the patients without renal replacement at the basement.
Measured: 3 months
Secondary outcomes (1)
kidney survival
patient and kidney survival at 12 month
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: The recruitment of subject is very difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisStudies 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
- 14 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
- Zhihong Liu, MD, Study director, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294344
- Sponsor's protocol ID
- NJCT1403
- Status last verified
- Feb 2018
- First submitted
- 3 Jun 2014
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled Study of Double Filtration Plasmapheresis (DFPP) in Patients With Antineutrophil Cytoplasmic Autoantibody Associated Glomerulonephritis (AAGN)
- ClinicalTrials.gov ID
- NCT02294344
- Acronym / sponsor ID
- NJCT1403
- Keywords
- double filtration plasmapheresis, ANCA-Associated Vasculitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment of subject is very difficult.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Nov 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 clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
Detailed description
This is a single center, prospective, randomized,controlled study to compare the clinical efficacy of double filtration plasmapheresis (DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy versus IV-CTX pulse therapy in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFPP&CTX | Experimental | Other: DFPP&CTXdouble filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP\&CTX) |
| cyclophosphamide | Active comparator | Drug: CTXcyclophosphamide(CTX) pulse therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of ANCA associated vasculitis(AAV), using criteria adapted from the disease definitions of the Chapel Hill consensus conference
- serum positive ANCA and the ANCA level ≥100 relative unit/ml
- with renal involvement and serum creatinine≥3 mg/dl
- written informed consent had been provided.
Key exclusion criteria (8 listed)
- other secondary vasculitis
- anti-glomerular basement membrane(GBM) positive
- severe infection; hepatitis B antigenemia, anti- hepatitis C virus
- immunodeficiency; or immunoglobulin G(IgG)<2g/l
- life threatening
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 |
|---|---|---|
| DFPP&CTXAlso: Double Filtration Plasmapheresis +cyclophosphamideFirst,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy. Then double volume of plasma was processed during each DFPP session every two day. A fraction plasma separator(Asahi Kasei Medical, surface area 2.0 m2,pore size 0.03 mm)and another fraction plasma separator (Asahi Kasei Medical, surface area 2.0 m2, pore size 0.01 mm)were used as first and second filter for plasma fractionation, respectively. 1.5 volume of plasma was processed, and 35~45g human albumin and blood plasma was supplemented during each session. The patients were treated with DFPP every two days for at least 3 times. After DFPP, 300-500ml blood plasma was supplemented. | Other | DFPP&CTX |
| CTXAlso: cyclophosphamideFirst,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy. After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study. The other patients after CTX pulse therapy for 6 months and achieve remission to receive oral maintenance therapy with azathioprine (AZA). The dosage of AZA was 1.0-2.0mg/kg/d(more than 50mg/d) and adjusted by white cell count and liver enzyme. If white cell count <3×109/L or an increase in liver enzyme to more than twice the normal upper limit, the dosage of AZA should be reduced. If white cell count <3×109/L or liver enzyme increased repeatedly, the patient would be withdrawn from the study. | Drug | cyclophosphamide |
Primary outcome
the renal recovery rate
Time frame: 3 months
the renal recovery rate at 3 mo defined by dialysis independence and the SCr <5mg/dl for the patients needed renal replacement therapy at the basement, or the SCr decreased more than 30% of the baseline and the urine sediment red blood cell less than 50*104/ml for the patients without renal replacement at the basement.
1 secondary outcome
kidney survival
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The recruitment of subject is very difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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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, MD study director
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DFPP&CTX and CTX in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, run by Zhi-Hong Liu, M.D. 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 8 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 6 Feb 2018. 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 was stopped early (reason given: The recruitment of subject is very difficult.). 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?
the renal recovery rate (time frame: 3 months). 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 6 Feb 2018.