The use of steroids in conjunction with antiretroviral therapy to treat HIV associated nephropathy to assist with treatment of renal function

The effects of add-on corticosteroids on renal outcomes in patients with biopsy-proven HIV-associated nephropathy: a single centre study from South Africa

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56112439

Enrollment

Registered

2018-09-05

Start date

2010-04-01

Completion date

Unknown

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV associated nephropathy Urological and Genital Diseases HIV-associated nephropathy (HIVAN)

Interventions

Participants were randomly allocated to 1 of 2 groups - either antiretroviral therapy (ART) and corticosteroids (1 mg/kg prednisone), or ART alone. Patients were assigned their treatment by randomly s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically-proven HIV-associated nephropathy, defined as having the presence of chronic tubulointerstitial inflammation with plasma cells, lymphocytes and microcysts, along with any of the following: 1.1. Collapsing glomerulopathy 1.2. Focal segmental glomerulosclerosis 1.3. Podocyte hypertrophy and/or hyperplasia 2. Antiretroviral therapy naïve for at least 2 weeks prior to renal biopsy 3. Initiation of antiretroviral therapy within 1 month of the renal biopsy 3. Aged 18 years or older 4. Able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Any active infection 2. Kaposi sarcoma 3. Active cytomegalovirus 4. Inability to follow-up at study centre

Design outcomes

Primary

Measure	Time frame
Improvement in the following renal outcomes in patients with glomerular or tubulointerstitial features of HIVAN as a result of corticosteroid therapy, from the at the baseline, then monthly for 6 months, then every 3 months for 2 years: 1. Improvement in estimated glomerular filtration rate (eGFR), assessed using the CKD EPI formula 2. Serum creatinine (mol/l), assessed using a blood test 3. Urine protein/creatinine ratio (uPCR) (g/mmol), assessed using a blood test	—

Measure

Time frame

Improvement in the following renal outcomes in patients with glomerular or tubulointerstitial features of HIVAN as a result of corticosteroid therapy, from the at the baseline, then monthly for 6 months, then every 3 months for 2 years: 1. Improvement in estimated glomerular filtration rate (eGFR), assessed using the CKD EPI formula 2. Serum creatinine (mol/l), assessed using a blood test 3. Urine protein/creatinine ratio (uPCR) (g/mmol), assessed using a blood test

—

Secondary

Measure	Time frame
1. Adverse events, assessed using death certificates, patient folders, records from HIV clinics and family members at every 3 months during the 2 year follow-up period 2. Improvements in the following histologies, assessed using a renal biopsy at the baseline and after 6 months: 2.1. Podocytopathy 2.2. Interstitial fibrosis 2.3. Lymphocytic cell infiltration 2.4. Plasma cell infiltration	—

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026