Overview

ACTHar in the Treatment of Lupus Nephritis

Status:
Recruiting

Trial end date:
2024-07-01

Target enrollment:
0

Participant gender:
All

Summary

Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body. About 50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to determine the effectiveness and safety of two dosing arms of ACTHar gel in treating proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar are safe and effective in treating proliferative LN (Class III and IV).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Columbia University

Treatments:

Adrenocorticotropic Hormone
Mycophenolate mofetil
Mycophenolic Acid

Criteria

Inclusion Criteria:

1. Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology
(ACR)/SLICC criteria

2. Age ≥ 16 years

3. Active lupus nephritis defined by:

a. Kidney biopsy documentation of International Society of Nephrology/Renal Pathology
Society (ISN/RPS) Class III or Class IV proliferative nephritis (including Class V
occurring in combination with Class III or IV) within 12 months and a urine
protein/creatinine ratio >1 at time of entry to study

4. Ability to provide informed consent

Exclusion Criteria:

1. Moderately severe anemia (Hgb < 8 mg/dL)

2. Neutropenia (< 1,000/mm3)

3. Thrombocytopenia (platelets < 50,000/mm3)

4. Positive purified protein derivative (PPD) test confirmed by positive Quantiferon TB
gold.

5. Pulmonary fibrotic changes on chest radiograph consistent with prior healed
tuberculosis

6. Active infections that in the opinion of the investigator increase the risks to the
subject.

7. Known human immunodeficiency virus (HIV) and hepatitis B or C

8. End-stage renal disease (estimated GFR clearance < 20 mL/min/1.73 m2)

9. History of cancer, except carcinoma in situ and treated basal and squamous cell
carcinomas

10. Pregnancy

11. Lactation

12. Unwillingness to use a medically acceptable form of birth control (including but not
limited to a diaphragm, an intrauterine device, progesterone implants or injections,
oral contraceptives, the double-barrier method, or a condom)

13. Previous failure to respond to MMF

14. Use of rituximab within the past year

15. Use of experimental therapeutic agents within the past 60 days

16. Greater than or equal to 5 times the upper limit of normal of liver function tests
(aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline
phosphatase)

17. Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal,
pulmonary, cardiac, or neurological disease (or, in the investigator's opinion, any
other concomitant medical condition that places the participant at risk by
participating in this study) with the exception of diseases or conditions related to
active SLE

18. Current substance abuse