Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis
Recruiting
N/AInterventional Study
Lupus Nephritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
206 (estimated)
Sponsor
Karolinska Institutet · Other
Who this trial is looking for
This trial is looking for patients with lupus who have developed kidney problems. Participants will receive standard treatment and may have a follow-up kidney biopsy 12 months later.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with systemic lupus erythematosus (SLE).
I am 18 years of age or older.
I have a confirmed first episode of lupus nephritis.
I consent to a possible repeat kidney biopsy in 12 months.
I am starting specific lupus treatments as advised.
You may not be able to join if
I have antiphospholipid syndrome nephropathy.
I am pregnant at the start of the trial.
I have medical issues that prevent a kidney biopsy.
I cannot follow treatment plans.
I have other medical conditions that affect the trial results.
I cannot read or sign the informed consent form.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 e…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Fulfilment of the EULAR/ACR classification criteria of SLE.
* 18 years of age or above.
* Incident biopsy-proven proliferative or membranous LN, or combinations thereof (with UPCR ≥ 1 g/g), i.e. 2003 ISN/RPS class III (A or A/C) ± V, class IV (A or A/C) ± V, or class V.
* Cons…
Inclusion Criteria:
* Fulfilment of the EULAR/ACR classification criteria of SLE.
* 18 years of age or above.
* Incident biopsy-proven proliferative or membranous LN, or combinations thereof (with UPCR ≥ 1 g/g), i.e. 2003 ISN/RPS class III (A or A/C) ± V, class IV (A or A/C) ± V, or class V.
* Consent to the possibility of a repeat kidney biopsy at month 12 from baseline.
* Initiation of the following treatment regimens:
* intravenous pulses of methylprednisolone (total dose of 500-3000 mg);
* oral prednisone or equivalent 0.3-0.5 mg/kg/day with tapering;
* hydroxychloroquine unless contraindicated;
* angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs);
* either one of mycophenolate mofetil (MMF) equivalent dose 2-3 g/day, or IV cyclophosphamide (CYC) according to the Euro-Lupus regimen;
* the NIH protocol for IV CYC (0.5-0.75 g/m2 monthly for six months) could be considered in severe cases;
* add-on therapies (e.g. calcineurin inhibitors, biologics) to the above two regimens are optional.
Exclusion Criteria:
* Antiphospholipid syndrome nephropathy (APSN).
* Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
* Medical contraindications to kidney biopsy, e.g. thrombocytopenia \< 50,000/μL, uncontrolled hypertension or end-stage kidney disease (ESKD).
* Anticipated non-adherence to therapy.
* Medical conditions interfering with outcome evaluations.
* Inability to read and/or sign the informed consent form.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.