Comprehensive Lupus Nephritis Treatment Protocol

Introduction

This innovative treatment protocol addresses the specific needs of lupus nephritis patients by providing a structured and effective approach to managing kidney inflammation and preserving renal function. Targeting immune pathways associated with lupus-induced kidney damage, this protocol offers an advanced strategy for symptom relief and long-term care, enhancing patient outcomes. For pharmaceutical companies, nephrology specialists, and healthcare providers, this technology represents an essential addition to the lupus nephritis treatment landscape, supporting better patient management in both acute and chronic stages of the condition.

The Challenge: Limited Treatment Options for Lupus Nephritis

Lupus nephritis, a severe complication of systemic lupus erythematosus, significantly impacts kidney function and increases the risk of chronic renal disease. Currently, available treatments often involve generalized immunosuppression, which may not fully address the disease’s complex pathways and can lead to side effects. The lack of targeted therapies results in a need for treatment protocols that can both reduce kidney inflammation and prevent progression to renal failure, improving quality of life for lupus patients while minimizing adverse effects.

Targeted Protocol for Symptom Relief and Kidney Protection

This protocol for lupus nephritis offers a comprehensive, structured approach to reducing kidney inflammation and protecting renal function. By focusing on targeted immune modulation, it reduces the immune attack on kidney tissues while managing symptoms such as pain, swelling, and fluid retention. The protocol provides a clear and manageable pathway for patients and healthcare providers to follow, improving adherence and treatment outcomes. With specific guidelines and a focus on preserving kidney function, this protocol delivers measurable improvements in patients’ renal health and overall well-being.

Key Benefits for Pharmaceuticals and Healthcare Providers

For pharmaceutical companies, this protocol offers an opportunity to create products that align with the latest advancements in lupus nephritis treatment. Healthcare providers and nephrologists can incorporate this protocol to better address inflammation and renal protection in patients, helping to reduce hospitalizations and improve patient care standards. The protocol’s targeted approach ensures it can be used alongside existing therapies, providing a holistic solution for managing lupus nephritis in both clinical and outpatient settings. Its focus on effective, long-term care makes it a valuable resource for healthcare providers committed to better outcomes for lupus patients.

Invest in Advanced Lupus Nephritis Care

Licensing this lupus nephritis treatment protocol positions your company as a leader in autoimmune disease care. By offering a targeted, effective approach for managing kidney inflammation and preserving renal function, your business can meet the growing demand for comprehensive lupus nephritis solutions. This technology is a valuable investment for companies focused on advancing nephrology care, improving patient outcomes, and leading in the field of autoimmune treatment.

Please see terms and conditions

Abstract
Claims

By employing a pharmacodynamic dosing regimen, the effectiveness of a protocol for treatment of lupus nephritis with voclosporin can be maximized while minimizing undesirable side effects.

1. A pharmacodynamic method to treat a proteinuric kidney disease which method comprises a protocol that consists of administering to a subject diagnosed with said disease a predetermined daily dosage of effective amounts of voclosporin over a projected treatment period of at least 24 weeks, said pharmacodynamic method further comprising:

(a) assessing the estimated Glomerular Filtration Rate (eGFR) of said subject at at least a first time point and a second time point on different days of said treatment period, and

(b) (i) if the eGFR of said subject decreases by more than a target % to below a predetermined value between said first and second time points, reducing the daily dosage by increment(s) of 7.9 mg BID or stopping the administering of voclosporin to said subject;

(ii) if the eGFR of said subject decreases by less than said target % between said first and second time points, continuing administering the same predetermined daily dosage of voclosporin to said subject.

2. The method of claim 1 wherein the first time point is immediately preceding initiating said protocol.

3. The method of claim 1 wherein the predetermined value is in the range of 50-90 ml/min/1.73 m².

4. The method of claim 1 wherein the target % is in the range of 20-45%.

5. The method of claim 3 wherein the predetermined value is approximately 60 ml/min/1.73 m².

6. The method of claim 4 wherein the target % is approximately 30%.

7. The method of claim 1 which further includes identifying said subject as appropriate for said method prior to conducting said method on said subject by evaluating the conditions that:

(a) determining that the urine protein creatinine ratio (UPCR) of said subject is ≥1 mg/mg as measured by first morning void or 24 hour urine; and

(b) determining said subject has an eGFR as measured by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EP1) of ≥45 ml/min/1.73 m²,

wherein if the conditions of (a) and (b) are met, said subject is identified as appropriate for said method.

8. The method of claim 1 wherein said predetermined daily dosage is 39.5. mg voclosporin BID or 31.6 mg voclosporin BID or 23.7 mg voclosporin BID or 15.8 mg voclosporin BID or 7.9 mg voclosporin BID.

9. The method of claim 1 wherein said method further includes evaluating said subject for renal function at a time point after the end of said treatment period by assessing eGFR.

10. The method of claim 9 wherein said method further includes evaluating said subject for maintaining renal function by assessing protein/creatinine ratio (UPCR) at a time point after the end of said treatment period.

11. The method of claim 1 wherein said method further includes administering to said subject an effective amount of mycophenolate mofetil (MMF).

12. The method of claim 1 which further includes administering to said subject an effective amount of a corticosteroid.

13. The method of claim 1 wherein said treatment period is at least 48 weeks.

14. The method of claim 1 which further includes determining the eGFR of said subject at a third time point and if the eGFR is determined at said third time point to differ from the eGFR determined at said first time point by less than said target %, resuming administering said predetermined daily dosage of voclosporin.

15. The method of claim 14 wherein the target % is 20-45%.

16. The method of claim 15 wherein the target % is approximately 30%.

Title

Protocol for treatment of lupus nephritis

Inventor(s)

Neil SOLOMONS, Robert B. HUIZINGA

Assignee(s)

Aurinia Pharmaceuticals Inc

Patent #

20180325995

Patent Date

November 15, 2018