The role of steroids in infection-related glomerulonephritis
ISRCTN | ISRCTN13723530 |
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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
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
Public
Institute of Nephrology
Rajiv Gandhi Government General Hospital
Chennai
600 003
India
Phone | +91 (0)9840755250 |
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tanujlamech@gmail.com |
Study information
Study design | Open-label single-centre randomized controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | A randomized controlled trial of corticosteroids in infection-related glomerulonephritis |
Study objectives | Infection-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) studied | Infection-related glomerulonephritis |
Intervention | Patients 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Methylprednisolone, prednisolone |
Primary outcome measure | Complete 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 measures | 1. 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 date | 01/04/2016 |
Completion date | 30/11/2020 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 86 |
Total final enrolment | 86 |
Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 06/09/2017 |
Date of final enrolment | 31/05/2020 |
Locations
Countries of recruitment
- India
Study participating centre
Chennai
600 003
India
Sponsor information
University/education
Park Town
Chennai
600 003
India
Phone | +91 (0)8939732516 |
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mmcnephro@gmail.com | |
Website | http://www.mmc.tn.gov.in/ |
https://ror.org/050ztxn78 |
Funders
Funder type
University/education
No information available
Results and Publications
Intention to publish date | 31/12/2021 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not expected to be made available |
Publication and dissemination plan | 1. The study protocol will be available on request 2. Planned publication in a peer-reviewed journal |
IPD sharing plan | Data not available due to ethical/legal restrictions |
Editorial Notes
16/02/2021: Trial's existence confirmed by the Institutional Ethics Committee, Madras Medical College.