Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Age
16–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Lupus nephritis patients
Patients with de novo or flaring SLE according to the EULAR/ACR criteria and a suspicion of class III or IV LN with a clinical indication to perform a kidney biopsy
Age 16-70 years
eGFR as measured by cystatin C \>20 mL/min
Diagnosis of SLE according to EULAR/ACR guidelines
Age 16-70
Blank medical history
Age 16-70
A majority (75%) of female healthy subjects will be sought
You may not be if
LN class I, II or pure class V upon kidney biopsy
eGFR as measured by cystatin C \<20 mL/min
Histological chronicity score (NIH) of 8 or higher in the kidney biopsy
Active infection of any kind as evidenced by cultures (blood, urine or otherwise)
History of hepatitis B, hepatitis C, tuberculosis and/or HIV
Treatment with any of the following agents within one month before screening:
tacrolimus, belimumab, anifrolumab - Treatment with any of the following agents within 6 months before screening: rituximab, daratumumab, eculizumab
Prolongation of QT-interval (QTc \>470ms) and/or bradycardia (resting heart rate \<50bpm) measured on two separate occasions
Hyperkalaemia (serum potassium \>6.0 mmol/L)
Hypertension (blood pressure \> 165/105 mmHg, with symptoms of hyperten sion)\*
Co-administration of voclosporin with strong CYP3A4 inhibitors (e.g., ke toconazole, itraconazole, clarithromycin)
Pregnancy
* A single elevated blood pressure measurement will not lead to immediate exclusion from the trial. Antihypertensive therapy may be initiated as appropriate. Dose adjustments of voclosporin should be made in accordance with Section 11.3.2 of the protocol
Suspicion of LN
Signs of active infection
\- Signs of active infection
Clareo Health | Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone
