Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis (REBIOLUP)
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|ClinicalTrials.gov Identifier: NCT04449991|
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : April 1, 2021
Lupus nephritis (LN) is one of the most severe complications of systemic lupus erythematosus (SLE). Among people living with SLE, 35-60% will develop LN during the course of the disease. This complication is one of the factors that contribute to deterioration of the renal function.
Some centres perform kidney biopsies after completion of treatment for an episode of LN as a part of the treatment evaluation. The term "repeat biopsy" is often used to describe these biopsies. Several studies have reported that repeat kidney biopsies show activity at the level of tissue, even in patients with normal routine blood and urine markers. The investigators strongly believe that this information is important, and should be taken into consideration during decision of treatment. To provide evidence for this, the investigators have designed a collaborative project within the frame of the Lupus Nephritis Trials Network. With this research project, the investigators want to contribute to an increased proportion of patients with LN who achieve remission (inactivity) of LN, and a reduced proportion of patients who worsen in renal function in the long term.
Patients with SLE who develop a first episode of LN will be asked to participate in this project, and will receive treatment according to current guidelines. Half of the patients will undergo a repeat biopsy 12 months later, and half of the patients will not. The selection of patients who will undergo or not undergo repeat biopsy will be random. Patients with high disease activity at the level of kidney tissue will receive more intense immunosuppressive treatment. Patients who have not undergone repeat biopsy will continue to be treated according to standard routine.
The investigators will compare the results of treatment between the group of patients who underwent and the group of patients who did not undergo repeat biopsy, with regard to (i) complete disease inactivity at month 24 and (ii) renal function at month 60 from treatment initiation.
The investigators expect that significantly greater proportions of patients in the repeat biopsy group will have inactive disease at month 24 and adequate levels of renal function at month 60. This will provide support for performing repeat biopsies as a part of the treatment evaluation, in order to optimise the therapeutic management and improve the long-term prognosis of patients with LN.
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Procedure: Repeat kidney biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||At baseline, patients will be randomised 1:1 to either undergo or not undergo a per-protocol repeat kidney biopsy at month 12 from baseline.|
|Masking:||None (Open Label)|
|Official Title:||Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2028|
Experimental: Intervention arm: Repeat kidney biopsy at M12
Patients will undergo repeat kidney biopsy at month 12 from baseline.
Procedure: Repeat kidney biopsy
Intensification of immunosuppression if NIH AI > 3
No Intervention: Control arm: No repeat kidney biopsy
Patients will not undergo repeat kidney biopsy at month 12 from baseline.
- Complete Renal Response (CRR) at month 24 from baseline [ Time Frame: Month 24 from baseline ]UPCR ≤ 0.5 g/g in two consecutive first-morning void urine specimens and no increase in serum creatinine by ≥ 25% from baseline.
- Renal function impairment at month 60 [ Time Frame: Month 60 from baseline ]Sustained (i.e. observed in at least two consecutive measurements on different dates) increase in serum creatinine by ≥ 25% from baseline.
- Renal relapse (proteinuric flare) [ Time Frame: Between month 12 and month 60 from baseline ]Reappearance of UPCR > 1.0 g/g from month 12 onwards, leading to intensification or change of immunosuppressive therapy. This increased proteinuria has to be sustained (i.e. observed in at least two consecutive measurements on different dates), occurring after an initial response to induction therapy (defined as sustained UPCR < 0.5 g/g).
- Reabsorption of immune deposits in repeat kidney biopsies [ Time Frame: Month 12 from baseline ]≥ 50% decrease in intensity and amount of immune deposits in electron microscopy.
- End-stage kidney disease (ESKD) [ Time Frame: Between month 12 and month 60 from baseline ]Chronic kidney disease stage 5 and/or dialysis will be used to assess ESKD.
- Mortality rate [ Time Frame: Between month 12 and month 60 from baseline ]The number of deaths during the study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449991
|Contact: Ioannis Parodis, MD PhDfirstname.lastname@example.org|
|Contact: Farah Tamirou, MD PhDemail@example.com|
|Study Chair:||Ioannis Parodis, MD PhD||Karolinska Institutet|
|Study Chair:||Farah Tamirou, MD PhD||Université Catholique de Louvain|
|Study Chair:||Julia Weinmann-Menke, MD PhD||Johannes Gutenberg University Mainz|
|Study Chair:||Hans-Joachim Anders, Professor||Ludwig-Maximilians - University of Munich|
|Study Chair:||Brad H Rovin, Professor||Ohio State University|
|Study Chair:||Frédéric A Houssiau, Professor||Université Catholique de Louvain|