Questions & Answers
1When is the trial planned to start?
The first study participant is expected to be enrolled in January 2021.
2How is data collection conducted?
Data collection is conducted through an electronic CRF platform administered at the Karolinska Institutet. Investigators are provided with links to the eCRFs, one for each visit.
3How long time does it take to complete the eCRF for a visit?
It takes differently long time depending on the visit. You can see the instruments constituting the eCRFs in the section Assessments and eCRFs. The longest data registration is for baseline, since it includes the EULAR/ACR classification criteria for SLE and kindey histopathology. Even if some instruments seem to be long, data in several sections within the instruments are automatically imputed by the eCRF system.
4My patient has been randomised to the control arm (no repeat kidney biopsy), but has worsened and I want to perform a repeat biopsy. Does the patient have to be excluded from ReBioLup due to protocol violation?
No, a repeat kidney biopsy due to worsening does not constitute a protocol violation. The repeat kidney biopsy in this case is not a per-protocol repeat kidney biopsy, and the incidence has to be registered as a flare. In the initial analysis, the patient will be analysed in the arm they were assigned. In secondary analyses, the patient might be analysed in the opposite arm, depending on when the biopsy was performed.
5My centre is participating in a clinical trial for a new therapeutic modality for lupus nephritis. Is participation in ReBioLup possible?
It depends on the design of the clinical trial. If the interventional part of the clinical trial is limited to one year, then it is possible since the first year of ReBioLup is observational, not interventional. The randomization for ReBioLup is always conducted at baseline, but the interventional part of ReBioLup starts from month 12 when the repeat kidney biopsy (for 50% of the patients) has been performed and will steer the intensity of immunosuppression.
6Is the kidney pathology assessment centrally conducted?
No, kidney pathology is assessed at the participating centres (for the purpose of therapeutic decision making), but slides will be sent to UCLouvain for digitalisation and central review (for the purpose of analysis).
7Is the collection of kidney tissue complicated?
The tissue collection procedure has been designed to be simple. Two very small fragments obtained from the kidney biopsies (no larger than a pinhead) will be isolated, dropped into a 2.5% glutaraldehyde solution (together), and stored at 4 °C until shipment to the coordinating centre UCLouvain.
8The kidney biopsy is an invasive procedure. Has there any risk/benefit assessment been conducted?
Yes, please contact the ReBioLup coordinator at [email protected] and ask for the risk/benefit profile of ReBioLup.
9Is any fee provided to the participating centres?
Yes, a small fee per patient enrolled will be provided to the participating sites. However, since ReBioLup is an investigator-initiated endeavour, this fee is limited.
More Questions & Answers are on the way.
In the meantime, please contact us at [email protected] if you have any questions.