The role of steroids in infection-related glomerulonephritis

ISRCTN ISRCTN13723530
DOI https://doi.org/10.1186/ISRCTN13723530
Submission date
08/02/2021
Registration date
28/02/2021
Last edited
22/02/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Infection-related glomerulonephritis is inflammation of the tiny filters in the kidneys (glomeruli) caused by infection. Given the role of immune activation in the disease, there has been interest in the use of immunosuppression to improve clinical outcomes. The aim of this study is to find out whether the use of steroids can improve renal (kidney) outcomes in patients with infection-related glomerulonephritis.

Who can participate?
Patients aged over 18 with infection-related glomerulonephritis

What does the study involve?
Participants are randomly allocated to receive either standard care or standard care plus corticosteroids. Participants allocated to corticosteroids are given intravenous methylprednisolone (into a vein) on 3 consecutive days, followed by oral prednisolone for 1 month, followed by a slow taper at 5 mg/week. Disease remission is assessed after 6 months, or at the time of the last follow-up, whichever is earlier.

What are the possible benefits and risks of participating?
The use of corticosteroids may improve renal outcomes in patients with infection-related glomerulonephritis. There is a potential risk of steroid toxicity.

Where is the study run from?
Institute of Nephrology, Rajiv Gandhi Government General Hospital (India)

When is the study starting and how long is it expected to run for?
April 2016 to December 2021

Who is funding the study?
Madras Medical College (India)

Who is the main contact?
Dr Tanuj Moses Lamech
tanujlamech@gmail.com

Contact information

Dr Tanuj Lamech
Public

Institute of Nephrology
Rajiv Gandhi Government General Hospital
Chennai
600 003
India

Phone +91 (0)9840755250
Email tanujlamech@gmail.com

Study information

Study designOpen-label single-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA randomized controlled trial of corticosteroids in infection-related glomerulonephritis
Study objectivesInfection-related glomerulonephritis is an immune-complex disease. This study tests the hypothesis that steroids ameliorate the deleterious consequences of immunological activation, and improve outcomes in patients with infection-related glomerulonephritis.
Ethics approval(s)Approved 05/09/2017, Institutional Ethics Committee, Madras Medical College (Madras Medical College, EVR Periyar Salai, Park Town, Chennai 600 003, India; Telephone number: +91 (0)44 25363970; ethicsmmc@gmail.com), ref: 18092017
Health condition(s) or problem(s) studiedInfection-related glomerulonephritis
InterventionPatients meeting the inclusion criteria are randomized 1:1, in blocks of 4, to receive either standard care (control arm), or standard care plus corticosteroids (intervention arm). Patients randomized to the intervention arm are given pulses of intravenous methylprednisolone (1 g) on 3 consecutive days. This is followed by oral prednisolone 1 mg/kg/day for 1 month, followed by a slow taper at 5 mg/week. No matching placebo was provided to the control arm, and the trial was open-label.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Methylprednisolone, prednisolone
Primary outcome measureComplete remission, defined as an estimated glomerular filtration rate (eGFR) of >60 ml/min/1.73m², assessed at 6 months after randomisation, or at time of last follow-up, whichever is earlier
Secondary outcome measures1. Combined complete remission (defined as eGFR >60 mL/min/1.73m² at 6 months) and partial remission (defined as serum creatinine lower than peak creatinine during initial admission, along with eGFR <60 mL/min/1.73m² at 6 months)
2. Death and end-stage renal disease (taken from the patient's medical records) at 6 months
3. Persistent proteinuria (urine PCR >0.5 or dipstick 2+ or more) at 6 months
4. Dialysis independence at any point within 6 months since randomization, among patients with dialysis-requiring renal failure at initial presentation (taken from the patient's medical records)
Overall study start date01/04/2016
Completion date30/11/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants86
Total final enrolment86
Key inclusion criteria1. Patients older than 18 years who provide written informed consent
2. Fulfilment of 3/5 of the Nasr et al. criteria for infection-related glomerulonephritis
3. Serum creatinine >1.5 mg/dl at time of randomisation
Key exclusion criteria1. More than 21 days elapsed since presentation
2. Presence of a contraindication for steroids
3. Seropositivity for HIV, hepatitis B, or hepatitis C
4. Hypocomplementaemia at 3 months
5. IgA-dominant infection-related glomerulonephritis
6. Crescents involving >50% of the sampled glomeruli
7. Diabetic nephropathy class III or IV
8. Interstitial fibrosis and tubular atrophy >40%
Date of first enrolment06/09/2017
Date of final enrolment31/05/2020

Locations

Countries of recruitment

  • India

Study participating centre

Rajiv Gandhi Government General Hospital
Park Town
Chennai
600 003
India

Sponsor information

Madras Medical College
University/education

Park Town
Chennai
600 003
India

Phone +91 (0)8939732516
Email mmcnephro@gmail.com
Website http://www.mmc.tn.gov.in/
ROR logo "ROR" https://ror.org/050ztxn78

Funders

Funder type

University/education

Madras Medical College

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination plan1. The study protocol will be available on request
2. Planned publication in a peer-reviewed journal
IPD sharing planData not available due to ethical/legal restrictions

Editorial Notes

16/02/2021: Trial's existence confirmed by the Institutional Ethics Committee, Madras Medical College.