Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy

Phase

2/3

Condition

Renal Failure

Kidney Failure (Pediatric)

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT02647255

RESCUE

Ages 14-65
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

<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
With diabetes or uncontrollable malignant hypertension or Thrombotic Microangiopathy
With Malignancy
Chronic active infection including HBV hepatitis C virus (HCV) HIV or activetuberculosis
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 thetreating physician.

Study Design

March 01, 2016

October 31, 2020

Study 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.

Connect with a study center

Renal Division, Department of Medicine, Peking University First Hospital
Beijing, Beijing 100034
China
Site Not Available
Renal division, Peking University First Hospital
Beijing, Beijing 100034
China
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.