Study of an investigational drug for lupus nephritis in combination with CellCept® and prednisone
Study Title: Dose Finding, Efficacy and Safety of an investigational study medication in Patients with Lupus Nephritis
Sponsor: Boehringer Ingelheim
Purpose: The purpose of this study is to evaluate an investigational study medication for lupus nephritis, when used in conjunction with CellCept® and prednisone (corticosteroids)
To take part in this study, you must:
- Be 18 – 70 years old
- Have a diagnosis of systemic lupus erythematosus (SLE)
- Have had a kidney biopsy within the last six months indicating lupus nephritis class III or IV with
- active or active/chronic nephritis (co‐existing class V permitted)
- Proteinuria > 1g/day or urine protein creatinine ratio (UPCR) ≥ 1.0 at screening
- Not be pregnant or breast feeding
- Using adequate contraceptive precautions if of childbearing age
- Other protocol defined exclusion criteria could apply and should be discussed with the study doctor.
What does this research study in lupus nephritis involve?
If you meet all study requirements you will go to the study clinic for up to 18 visits over approximately 15 months. Each visit will take approximately two‐four hours. You may also be asked to come in for extra visits for routine blood samples or other assessments throughout the study.
You will be given either the study drug or a placebo for 12 months. You will be randomly assigned (similar to flipping a coin) to receive one of 3 different doses of the study medication or placebo as a study medication on top of standard of care medication such as CellCept® ( mycophenolate mofetil ‐MMF) and steroids. You will have a two out of three (67%) chance to receive the study medication. Study medication and study related medical care will be provided at no cost to you. The study medication is injected subcutaneously (under the skin) weekly over the 12 month period.
Approximately one hundred and twenty (120) participants will participate in this study at multiple sites in North America, Europe, Asia and Australia. You may be eligible to receive additional study medication for up to 2 years in a maintenance study if you show a response to the study medication at the end of this study.
If you are in the study, you may have the following procedures and tests done during the study period:
- A complete physical examination and review of medical history
- Review of any adverse events and/or other medications that you take
- Assessment of lupus activity
- Monitoring of vital signs (blood pressure, heart rate)
- Blood and urine sampling
- Electrocardiogram (ECG)
- An assessment of your reported outcomes
For more information, please visit www.lupusnephritisstudies.com.
The Lupus Foundation of America works to educate and inform about clinical trial study options available to people with lupus and the importance of getting involved to help advance lupus research. The Lupus Foundation of America does not endorse specific trials.