BridgeMD
New treatment option for Lupus Nephritis
Official title Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis
ClinicalTrials.gov ID: NCT04449991
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Consent to the possibility of a repeat kidney biopsy at month 12 from baseline.
- Initiation of the following treatment regimens:
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.