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Tests treatment safety and results for Lupus Nephritis
Official title Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
ClinicalTrials.gov ID: NCT07225387
What this study is testing
What is Voclosporin?
Voclosporin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.
- Phase 4: studies an already-approved treatment
- 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 to 80
You may be able to join if
- Signed Informed Consent Form
- Age 18-80 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- A diagnosis of SLE by any one of the following criteria: European League Against Rheumatism/ American College of Rheumatology/Systemic Lupus...
- At least one positive ANA defined as a \>1:80 titer or a positive anti-ds-DNA within the last 3 years will be accepted.
You likely can't join if
- 1\. Currently on renal replacement therapy (dialysis or a kidney transplant), has had dialysis within 3 months of screening or is expected to require...
- Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.
- Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be...
See the full eligibility criteria
- Signed Informed Consent Form
- Age 18-80 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- A diagnosis of SLE by any one of the following criteria: European League Against Rheumatism/ American College of Rheumatology/Systemic Lupus International Collaborating Clinics (EULAR/ACR/SLICC)
- At least one positive ANA defined as a \>1:80 titer or a positive anti-ds-DNA within the last 3 years will be accepted.
- ISN/RPS 2003 Class III, Class IV, Class III/V or Class IV/V Lupus Nephritis diagnosed and meet one of these criteria: i) A new diagnosis of LN (kidney biopsy current by SOC), or ii) A previous diagnosis of LN that has...
- UPCR must be \>750 mg/gm from a 24 hour urine collection during screening. If the UPCR does not exceed 750 mg/gm, it may be repeated once during the screening period.
- Resting systolic blood pressure \ 150/90 at screening it can be repeated twice in the screening period and if it is \<150/90 upon repeat the subject is eligible for study enrollment.
- Subject must be on maximum tolerated ACEi or ARB therapy as adjudicated by the site PI for ≥4 weeks prior to randomization. Note: Patients with confirmed ACEi or ARB intolerance defined as persistent cough, anaphylaxis...
- Use of other protein-lowering agents, including non-dihydropyridine calcium channel blockers, sodium-glucose transporter 2 (SGLT2) inhibitors, mineralocorticoid receptor antagonists (MRA), will be allowed provided...
- EGFR \>30 ml/min/1,73m2 will be required for kidney biopsies obtained \>3.0 months from the start of drug administration. EGFR\> 20 mls/min/1.73 m2 will be allowed for renal biopsies obtained \ 65% will be excluded from...
- Eligible patients will have adequate hematologic parameters defined below as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Absolute lymphocyte count (ALC) ≥ 1.0 x 109/L. Note: If count is between .5 x 109/L and 1.0 x 109/L , the site will consult with the study Medical Monitor(s) to determine eligibility.
- Platelet count \> 75 x 109/L
- Hemoglobin \> 8.5 g/dL
- people must be taking Belimumab prior to Consent / Screening or start on Day 0 / Baseline (randomization to short-term MMF or MPA therapy or extended MMF or MPA therapy). Note: If Belimumab therapy is expected for less...
- people of Child-Bearing Potential must use a highly effective method of contraception consistently and correctly during the study. Highly effective methods of contraception have a failure rate of \<1% per year when used...
- Combined hormonal (estrogen+progestin) contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation.
- Progestogen- or progestin-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation.
- Intrauterine device.
- Intrauterine hormone-releasing system.
- Bilateral tubal ligation/occlusion/division.
- Vasectomized partner (considered a highly effective birth control method provided that partner is the sole sexual partner of the study subject and that the vasectomized partner has received medical assessment of the...
- Sexual abstinence: defined as refraining from intercourse which may result in pregnancy during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated...
- 1\. Currently on renal replacement therapy (dialysis or a kidney transplant), has had dialysis within 3 months of screening or is expected to require renal replacement therapy within 6 months of screening 2. Received...
- Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.
- Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be assigned by chance. 9. Positive human immunodeficiency virus (HIV)...
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Atlanta, Georgia, United States
- Lawrenceville, Georgia, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Fort Worth, Texas, United States
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Atlanta, Georgia, United States; Lawrenceville, Georgia, United States; Columbus, Ohio, United States; Oklahoma City, Oklahoma, United States; Fort Worth, Texas, United States. 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.