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Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy (RESCUE)

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ClinicalTrials.gov Identifier: NCT02647255
Recruitment Status : Enrolling by invitation
First Posted : January 6, 2016
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hong Zhang, Peking University First Hospital

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE January 6, 2016
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02647255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • Renal remission [ Time Frame: 12 months after final subject is enrolled ]
    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
  • Proteinuria remission [ Time Frame: At the 12th month and 36th month after randomization ]
    Proteinuria remission: defined as proteinuria < 0.5g/d for ≥3months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 4, 2016)
Rate of serious adverse events [ Time Frame: From 12 months after first subject enrolled to 12 months after final subject is enrolled ]
Serious adverse events are defined as: Clinically apparent gastrointestinal haemorrhage requiring hospitalization or prolonging the time of hospitalization. Serious infections requiring hospitalization or prolonging the time of hospitalization. Severe allergic reaction requiring hospitalization or prolonging the time of hospitalization. Chronic viral infection, including HIV hepatitis B virus(HBV) and HCV Other adverse events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy
Official Title  ICMJE Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study)
Brief 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 methylprednisolone on a background of oral prednisolone and cyclophosphamide in prevent kidney failure.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glomerulonephritis, IGA
  • Kidney Diseases
  • Acute Renal Insufficiency
  • Rapidly Progressive Glomerulonephritis
Intervention  ICMJE
  • Procedure: Plasma Exchange (PE)
    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)
    Other Name: Plasmapheresis
  • Drug: Methylprednisolone pulse
    methylprednisolone 7-15mg/kg/d 3 times, Qd. or Qod
    Other Name: Intensive Immunosuppressive treatment
Study Arms  ICMJE
  • Experimental: PE and methylprednisolone pulse
    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.
    Interventions:
    • Procedure: Plasma Exchange (PE)
    • Drug: Methylprednisolone pulse
  • Active Comparator: Methylprednisolone pulse
    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.
    Intervention: Drug: Methylprednisolone pulse
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 4, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. <14 or >65 years old
  2. With high Scr requiring dialysis for≥ 3w
  3. Scr>200μmol/L ≥1 yr before entry
  4. Main of old crescent ; Fibrous crescent>50%
  5. Anti-glomerular basement membrane (GBM) or antineutrophil cytoplasmic antibody (ANCA) antibody positive
  6. Women in gestational and lactational period
  7. With diabetes or uncontrollable malignant hypertension or Thrombotic Microangiopathy
  8. With Malignancy
  9. Chronic active infection including HBV hepatitis C virus (HCV) HIV or active tuberculosis
  10. Other autoimmune disease
  11. A second clearly defined cause of renal failure
  12. Contraindication of plasma exchange treatment or steroid pulse
  13. Patients who are unlikely to comply with the study protocol in the view of the treating physician.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02647255
Other Study ID Numbers  ICMJE RESCUE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hong Zhang, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hong Zhang, MD, PHD Renal Division, Department of Medicine, Peking University First Hospital;Peking University Institute of Nephrology
PRS Account Peking University First Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP