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Regency - Clinical Research Study

This is a study to demonstrate the clinical efficacy and safety of obinutuzumab in participants with Lupus Nephritis.

Regency - Clinical Research Study

Minimum Age

18

18 Years and Older
No Older Than 75

Diagnosis

LN

Lupus Nephritis

PLACEBO CONTROLLED

Yes

Possible Placebo

DURATION

76

Total Duration is 76 Weeks

STIPEND

$86

$86 Per Completed Visit

Patient Benefits

Patients who screen and then enroll in the study will receive:

  • Doctor Assessments
  • Lab work and Safety Follow-ups
  • Study drug (active, comparator, or placebo)
  • $86.00 per completed study visit

Study Duration

Study Duration for Patients

The total study duration is approximately 76-weeks which consists of approximately 15 visits during the course of the study.

The study consists of three periods:

  1. Screening Period (2 to 4 weeks before the treatment starts) to see if you are eligible to participate in the study.
  2. Study Treatment Period (76 weeks). This Study Treatment period is double-blinded. Double-blind means you and your study team will not know which of the two treatment therapies you will receive, although your study doctor can find out if needed for your safety.
  3. Safety Follow-Up Visits (2 SFU visits) (Up to 52 weeks after the last dose of study drug) These visits will ensure you have no long-term safety concerns after the end of treatment. Your study doctor can extend this if necessary for safety concerns.

The study may also have some unplanned visits, most commonly for repeat lab work.

Study Drug

Obinutuzumab (Gazyva)

Obinutuzumab (Gazyva) is a monoclonal antibody therapy.

Enrolled subjects will either receive the investigational therapy (50%) or placebo (50%). All subjects will receive mycophenolate mofetil (Myfortic) as a standard of care treatment for the duration of the study.

Study Location

600 Aviator Ct.
Vandalia, OH 45377

Inclusion Criteria

The following must be met in order to qualify for the study.

  • Subjects must be at least 18 years of age, and no older than 75.
  • Active or chronic class III or IV Lupus Nephritis
  • Women must either be postmenopausal, surgically sterile, agree to use two forms of reliable contraception, or agree to abstain from heterosexual intercourse for the duration of the study.
  • Men must either be surgically sterile, use a condom plus an additional contraceptive method used by the female partner, or agree to abstain from heterosexual intercourse.
  • Men must agree not to donate sperm for the purpose of reproduction for a minimum of 90 days after receiving the last administration of mycophenolate mofetil.

Exclusion Criteria

Patients with any of the following are ineligible to enroll in the study.

  • Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
  • Subjects that have a human immunodeficiency virus (HIV) infection.
  • Subjects that have active tuberculosis (TB) infection.
  • Subjects with an intolerance to study therapies or a history of severe allergic reactions to monoclonal antibodies, or mycophenolate mofetil.

** Other eligibility criteria exist to enroll in the study.   Study eligibility requirements are subject to change.  STAT Research and Dr. Wolfe reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at anytime without prior notice.

How to contact us...

1-833-STAT-833

See if you Qualify!

Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.

We only will notify you of new studies enrolling, never any spam, and unsubscribe anytime.
A telephone number where we can contact you.

Study Investigator

Dr. Sanford Wolfe, D.O.
Dr. Sanford Wolfe, D.O.

Principal Investigator

Dr. Wolfe is a graduate of Des Moines University College of Osteopathic Medicine and has been practicing Rheumatology for over 40 years. Dr. Wolfe is board certified in Internal Medicine and Rheumatology. Dr. Wolfe is a renowned leader in regards to clinical research trials, with over 20 years of experience and led more than 120 studies within the Rheumatology therapeutic area.

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