Glomerulonephritis, IGAPhase 2/3RESCUENCT02647255

Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy

A Phase 2/3 study testing Plasma Exchange (PE) and Methylprednisolone pulse in people with Glomerulonephritis, IGA and Kidney Diseases, run by Peking University First Hospital at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Crescentic IgA nephropathy (CreIgAN) has a poor prognosis despite aggressive immunosuppressive therapy. The efficacy of plasma exchange (PE) in CreIgAN is not well defined. This study will evaluate the efficacy and safety of plasma exchange as adjunctive therapy for severe crescentic IgA nephropathy compared to pulse… Read more about this study

Who is it for?: Ages 14 to 65 years
Conditions the study is for: Glomerulonephritis, IGA, Kidney Diseases, Acute Renal Insufficiency
What is being tested?: Plasma Exchange (PE) and Methylprednisolone pulse
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesChina
Study dates: Mar 2016to Oct 2020
Phase: Phase 2/3
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 14 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Biopsy-proven within 3ws
Primary IgAN or Henoch-Schönlein Purpura nephritis of crescent >50%(>8 glomeruli)
Serum creatinine ≥ 200 μmol/l， rapidly deterioration of renal function

Who cannot join

<14 or >65 years old
With high Scr requiring dialysis for≥ 3w
Scr>200μmol/L ≥1 yr before entry
Main of old crescent ; Fibrous crescent>50%
Anti-glomerular basement membrane (GBM) or antineutrophil cytoplasmic antibody (ANCA) antibody positive
Women in gestational and lactational period

Show all 13Show fewer

With diabetes or uncontrollable malignant hypertension or Thrombotic Microangiopathy
With Malignancy
Chronic active infection including HBV hepatitis C virus (HCV) HIV or active tuberculosis
Other autoimmune disease
A second clearly defined cause of renal failure
Contraindication of plasma exchange treatment or steroid pulse
Patients who are unlikely to comply with the study protocol in the view of the treating physician.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Renal Division, Department of Medicine, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Renal division, Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study)

Read the detailed description

IgA nephropathy (IgAN) is one of the most common glomerulonephritides and is characterized by a highly variable clinical course and diverse histopathological lesions. Although most affected individuals develop chronic, slowly progressive renal injury, a subgroup of patients (<5% of all IgAN patients) with diffuse crescent formation, which is termed as crescentic IgA nephropathy (CreIgAN) and often leads to rapidly progressive kidney failure. The recent Kidney Disease: Improving Global Outcomes (KDIGO) guidelines suggest high-dose steroids and cyclophosphamide therapy for CreIgAN. However, this suggestion is mainly based on several small observational studies, and the 1- and 5-year renal survival rates of patients treated with this regimen were as low as 65% and 28%, respectively, in one large cohort of CreIgAN patients. The efficacy of plasma exchange (PE) in severe CreIgAN is not well evaluated, although several anecdotal reports have indicated benefit of PE in combination with immunosuppressive therapies in IgAN patients. Retrospective cohort study in our unite also supported the benefit of PE as additional therapy for CreIgAN patients. However, randomized controlled trial is needed to evaluate the efficacy and safety of plasma exchange as adjunctive therapy for crescentic IgA nephropathy compared to pulse methylprednisolone on a background of oral prednisolone and cyclophosphamide in prevent kidney failure.

Conditions: Glomerulonephritis, IGA, Kidney Diseases, Acute Renal Insufficiency, Rapidly Progressive Glomerulonephritis
Being tested: Plasma Exchange (PE), Methylprednisolone pulse
Keywords: crescentic IgA nephropathy, plasma exchange treatment or plasmapheresis, randomized controlled trial, intensive immunosuppressive treatment, methylprednisolone pulse
Medical subject headings: Glomerulonephritis, IGA, Kidney Diseases, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plasma Exchange (PE)Procedure or surgery
Also called Plasmapheresis
PE treatment>7 within 3weeks; Volume exchanged: 60ml/kg/course; Replacement fluid: 5% Albumin or fresh frozen plasma; PE was performed by dialysis machine (IQ-21, Asahi Japan) and plasma separator (OP- 08W, Asahi Japan)
Methylprednisolone pulseDrug
Also called Intensive Immunosuppressive treatment
methylprednisolone 7-15mg/kg/d 3 times, Qd. or Qod

Study groups in NCT02647255
Study group	Role	What they receive
PE and methylprednisolone pulse	Experimental	Plasma exchange(PE) and methylprednisolone pulse therapy: plasma exchange >7 within 3ws, Volume: 60ml/kg/course; Replacement fluid: 5% albumin or fresh frozen plasma and methylprednisolone pulse therapy Basic treatment: Oral prednisone was tapered from 1 mg/kg/d for 6wks, then diminish 5mg/d every 10d, stop at the sixth month; cyclophosphamide 1.5 mg/kg/d for 3 months, 50mg /d at 3 months and stopped at 6 month. Receives: Procedure: Plasma Exchange (PE); Drug: Methylprednisolone pulse
Methylprednisolone pulse	Active comparator	Methylprednisolone pulse alone: methylprednisolone 7-15mg/kg/d 3 times on consecutive or alternate days Basic treatment: Oral prednisone was tapered from 1 mg/kg/d for 6wks, then diminish 5mg/d every 10d, stop at the sixth month; cyclophosphamide 1.5 mg/kg/d for 3 months, 50mg /d at 3 months and stopped at 6 month. Receives: Drug: Methylprednisolone pulse

What is being measured

The primary outcome is the main question the study is designed to answer.

End-stage renal disease or death
End-stage renal disease: defined as a need for maintenance dialysis > 6 months; or need kidney transplantation , and death; during follow-up.
Measured: 12 months after final subject is enrolled

Secondary outcomes (2)

Renal remission
Renal remission: defined as the independent of dialysis, or serum creatinine under 200μmol/l within 6 months, and lasts without a first relapse until at least 12 months after randomization
Measured: 12 months after final subject is enrolled
Proteinuria remission
Proteinuria remission: defined as proteinuria < 0.5g/d for ≥3months
Measured: At the 12th month and 36th month after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Oct 2020

First posted6 Jan 2016 (estimated)
Study startMar 2016
Primary completionOct 2020
Study completionOct 2020

Why it stopped: Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Glomerulonephritis, IGAStudies of the same condition, open and under way.
More trials run by Peking University First 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02647255
Sponsor's protocol ID: RESCUE
Acronym: RESCUE
Status last verified: Sep 2021
First submitted: 21 Dec 2015
Last updated: 8 Oct 2021
Results posted: No
Data monitoring committee: Yes

Publications

Suzuki H, Kiryluk K, Novak J, Moldoveanu Z, Herr AB, Renfrow MB, Wyatt RJ, Scolari F, Mestecky J, Gharavi AG, Julian BA. The pathophysiology of IgA nephropathy. J Am Soc Nephrol. 2011 Oct;22(10):1795-803. doi: 10.1681/ASN.2011050464. Epub 2011 Sep 23.
PubMed 21949093
Lv J, Yang Y, Zhang H, Chen W, Pan X, Guo Z, Wang C, Li S, Zhang J, Zhang J, Liu L, Shi S, Wang S, Chen M, Cui Z, Chen N, Yu X, Zhao M, Wang H. Prediction of outcomes in crescentic IgA nephropathy in a multicenter cohort study. J Am Soc Nephrol. 2013 Dec;24(12):2118-25. doi: 10.1681/ASN.2012101017. Epub 2013 Sep 12.
PubMed 24029421
Abe T, Kida H, Yoshimura M, Yokoyama H, Koshino Y, Tomosugi N, Hattori N. Participation of extracapillary lesions (ECL) in progression of IgA nephropathy. Clin Nephrol. 1986 Jan;25(1):37-41.
PubMed 3955907
Tang Z, Wu Y, Wang QW, Yu YS, Hu WX, Yao XD, Chen HP, Liu ZH, Li LS. Idiopathic IgA nephropathy with diffuse crescent formation. Am J Nephrol. 2002 Sep-Dec;22(5-6):480-6. doi: 10.1159/000065281.
PubMed 12381947
Tumlin JA, Lohavichan V, Hennigar R. Crescentic, proliferative IgA nephropathy: clinical and histological response to methylprednisolone and intravenous cyclophosphamide. Nephrol Dial Transplant. 2003 Jul;18(7):1321-9. doi: 10.1093/ndt/gfg081.
PubMed 12808169
Pankhurst T, Lepenies J, Nightingale P, Howie AJ, Adu D, Harper L. Vasculitic IgA nephropathy: prognosis and outcome. Nephron Clin Pract. 2009;112(1):c16-24. doi: 10.1159/000210570. Epub 2009 Apr 3.
PubMed 19342865
Jayne DR, Gaskin G, Rasmussen N, Abramowicz D, Ferrario F, Guillevin L, Mirapeix E, Savage CO, Sinico RA, Stegeman CA, Westman KW, van der Woude FJ, de Lind van Wijngaarden RA, Pusey CD; European Vasculitis Study Group. Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis. J Am Soc Nephrol. 2007 Jul;18(7):2180-8. doi: 10.1681/ASN.2007010090. Epub 2007 Jun 20.
PubMed 17582159
Nicholls K, Becker G, Walker R, Wright C, Kincaid-Smith P. Plasma exchange in progressive IgA nephropathy. J Clin Apher. 1990;5(3):128-32. doi: 10.1002/jca.2920050303.
PubMed 2345159
Lai KN, Lai FM, Leung AC, Ho CP, Vallance-Owen J. Plasma exchange in patients with rapidly progressive idiopathic IgA nephropathy: a report of two cases and review of literature. Am J Kidney Dis. 1987 Jul;10(1):66-70. doi: 10.1016/s0272-6386(87)80014-8.
PubMed 3300287
Fujinaga S, Ohtomo Y, Umino D, Mochizuki H, Murakami H, Shimizu T, Yamashiro Y, Kaneko K. Plasma exchange combined with immunosuppressive treatment in a child with rapidly progressive IgA nephropathy. Pediatr Nephrol. 2007 Jun;22(6):899-902. doi: 10.1007/s00467-006-0428-4. Epub 2007 Feb 7.
PubMed 17285293
Nicholls K, Walker RG, Dowling JP, Kincaid-Smith P. "Malignant" IgA nephropathy. Am J Kidney Dis. 1985 Jan;5(1):42-6. doi: 10.1016/s0272-6386(85)80134-7.
PubMed 3966468
Roccatello D, Ferro M, Coppo R, Giraudo G, Quattrocchio G, Piccoli G. Report on intensive treatment of extracapillary glomerulonephritis with focus on crescentic IgA nephropathy. Nephrol Dial Transplant. 1995 Nov;10(11):2054-9.
PubMed 8643167
Schwartz J, Winters JL, Padmanabhan A, Balogun RA, Delaney M, Linenberger ML, Szczepiorkowski ZM, Williams ME, Wu Y, Shaz BH. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the Writing Committee of the American Society for Apheresis: the sixth special issue. J Clin Apher. 2013 Jul;28(3):145-284. doi: 10.1002/jca.21276.
PubMed 23868759
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PubMed 38299639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

All Glomerulonephritis, IGA trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study)
ClinicalTrials.gov ID: NCT02647255
Acronym / sponsor ID: RESCUE / RESCUE
Conditions: Glomerulonephritis, IGA, Kidney Diseases, Acute Renal Insufficiency, Rapidly Progressive Glomerulonephritis
Keywords: crescentic IgA nephropathy, plasma exchange treatment or plasmapheresis, randomized controlled trial, intensive immunosuppressive treatment, methylprednisolone pulse
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.
Enrolment: 10 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Oct 2020 (actual)
Study completion: Oct 2020 (actual)
First posted: 6 Jan 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PE and methylprednisolone pulse	Experimental	Procedure: Plasma Exchange (PE), Drug: Methylprednisolone pulsePlasma exchange(PE) and methylprednisolone pulse therapy: plasma exchange >7 within 3ws, Volume: 60ml/kg/course; Replacement fluid: 5% albumin or fresh frozen plasma and methylprednisolone pulse therapy Basic treatment: Oral prednisone was tapered from 1 mg/kg/d for 6wks, then diminish 5mg/d every 10d, stop at the sixth month; cyclophosphamide 1.5 mg/kg/d for 3 months, 50mg /d at 3 months and stopped at 6 month.
Methylprednisolone pulse	Active comparator	Drug: Methylprednisolone pulseMethylprednisolone pulse alone: methylprednisolone 7-15mg/kg/d 3 times on consecutive or alternate days Basic treatment: Oral prednisone was tapered from 1 mg/kg/d for 6wks, then diminish 5mg/d every 10d, stop at the sixth month; cyclophosphamide 1.5 mg/kg/d for 3 months, 50mg /d at 3 months and stopped at 6 month.

Who may qualify

Ages: 14 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Biopsy-proven within 3ws
Primary IgAN or Henoch-Schönlein Purpura nephritis of crescent >50%(>8 glomeruli)
Serum creatinine ≥ 200 μmol/l， rapidly deterioration of renal function

Key exclusion criteria (13 listed)

<14 or >65 years old
With high Scr requiring dialysis for≥ 3w
Scr>200μmol/L ≥1 yr before entry
Main of old crescent ; Fibrous crescent>50%
Anti-glomerular basement membrane (GBM) or antineutrophil cytoplasmic antibody (ANCA) antibody positive

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
Plasma Exchange (PE)Also: PlasmapheresisPE treatment>7 within 3weeks; Volume exchanged: 60ml/kg/course; Replacement fluid: 5% Albumin or fresh frozen plasma; PE was performed by dialysis machine (IQ-21, Asahi Japan) and plasma separator (OP- 08W, Asahi Japan)	Procedure or surgery	PE and methylprednisolone pulse
Methylprednisolone pulseAlso: Intensive Immunosuppressive treatmentmethylprednisolone 7-15mg/kg/d 3 times, Qd. or Qod	Drug	Methylprednisolone pulse, PE and methylprednisolone pulse

Primary outcome

End-stage renal disease or death
Time frame: 12 months after final subject is enrolled
End-stage renal disease: defined as a need for maintenance dialysis > 6 months; or need kidney transplantation , and death; during follow-up.

2 secondary outcomes

Renal remission
Time frame: 12 months after final subject is enrolled
Proteinuria remission
Time frame: At the 12th month and 36th month after randomization

Results and safety

The study was stopped early (reason given: Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
Background: PubMed 21949093Suzuki H, Kiryluk K, Novak J, Moldoveanu Z, Herr AB, Renfrow MB, Wyatt RJ, Scolari F, Mestecky J, Gharavi AG, Julian BA. The pathophysiology of IgA nephropathy. J Am Soc Nephrol. 2011 Oct;22(10):1795-803. doi: 10.1681/ASN.2011050464. Epub 2011 Sep 23.
Background: PubMed 24029421Lv J, Yang Y, Zhang H, Chen W, Pan X, Guo Z, Wang C, Li S, Zhang J, Zhang J, Liu L, Shi S, Wang S, Chen M, Cui Z, Chen N, Yu X, Zhao M, Wang H. Prediction of outcomes in crescentic IgA nephropathy in a multicenter cohort study. J Am Soc Nephrol. 2013 Dec;24(12):2118-25. doi: 10.1681/ASN.2012101017. Epub 2013 Sep 12.
Background: PubMed 3955907Abe T, Kida H, Yoshimura M, Yokoyama H, Koshino Y, Tomosugi N, Hattori N. Participation of extracapillary lesions (ECL) in progression of IgA nephropathy. Clin Nephrol. 1986 Jan;25(1):37-41.
Background: PubMed 12381947Tang Z, Wu Y, Wang QW, Yu YS, Hu WX, Yao XD, Chen HP, Liu ZH, Li LS. Idiopathic IgA nephropathy with diffuse crescent formation. Am J Nephrol. 2002 Sep-Dec;22(5-6):480-6. doi: 10.1159/000065281.
Background: PubMed 12808169Tumlin JA, Lohavichan V, Hennigar R. Crescentic, proliferative IgA nephropathy: clinical and histological response to methylprednisolone and intravenous cyclophosphamide. Nephrol Dial Transplant. 2003 Jul;18(7):1321-9. doi: 10.1093/ndt/gfg081.
Background: PubMed 19342865Pankhurst T, Lepenies J, Nightingale P, Howie AJ, Adu D, Harper L. Vasculitic IgA nephropathy: prognosis and outcome. Nephron Clin Pract. 2009;112(1):c16-24. doi: 10.1159/000210570. Epub 2009 Apr 3.
Background: PubMed 17582159Jayne DR, Gaskin G, Rasmussen N, Abramowicz D, Ferrario F, Guillevin L, Mirapeix E, Savage CO, Sinico RA, Stegeman CA, Westman KW, van der Woude FJ, de Lind van Wijngaarden RA, Pusey CD; European Vasculitis Study Group. Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis. J Am Soc Nephrol. 2007 Jul;18(7):2180-8. doi: 10.1681/ASN.2007010090. Epub 2007 Jun 20.
Background: PubMed 2345159Nicholls K, Becker G, Walker R, Wright C, Kincaid-Smith P. Plasma exchange in progressive IgA nephropathy. J Clin Apher. 1990;5(3):128-32. doi: 10.1002/jca.2920050303.
Background: PubMed 3300287Lai KN, Lai FM, Leung AC, Ho CP, Vallance-Owen J. Plasma exchange in patients with rapidly progressive idiopathic IgA nephropathy: a report of two cases and review of literature. Am J Kidney Dis. 1987 Jul;10(1):66-70. doi: 10.1016/s0272-6386(87)80014-8.
Background: PubMed 17285293Fujinaga S, Ohtomo Y, Umino D, Mochizuki H, Murakami H, Shimizu T, Yamashiro Y, Kaneko K. Plasma exchange combined with immunosuppressive treatment in a child with rapidly progressive IgA nephropathy. Pediatr Nephrol. 2007 Jun;22(6):899-902. doi: 10.1007/s00467-006-0428-4. Epub 2007 Feb 7.
Background: PubMed 3966468Nicholls K, Walker RG, Dowling JP, Kincaid-Smith P. "Malignant" IgA nephropathy. Am J Kidney Dis. 1985 Jan;5(1):42-6. doi: 10.1016/s0272-6386(85)80134-7.
Background: PubMed 8643167Roccatello D, Ferro M, Coppo R, Giraudo G, Quattrocchio G, Piccoli G. Report on intensive treatment of extracapillary glomerulonephritis with focus on crescentic IgA nephropathy. Nephrol Dial Transplant. 1995 Nov;10(11):2054-9.
KDIGO Clinical Practice Guideline for Glomerulonephritis (GN)Link provided by the sponsor.

Related trials for Glomerulonephritis, IGA

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

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.

Hong Zhang, MD, PHD study director

Renal Division, Department of Medicine, Peking University First Hospital;Peking University Institute of Nephrology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Plasma Exchange (PE) and Methylprednisolone pulse in people with Glomerulonephritis, IGA and Kidney Diseases, run by Peking University First Hospital 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 13 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 8 Oct 2021. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

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?

End-stage renal disease or death (time frame: 12 months after final subject is enrolled). 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 NCT02647255, which also lists 14 linked publications.

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 8 Oct 2021.