Is NCT05538208 recruiting in Hackensack, NJ?

Yes, NCT05538208 is currently recruiting participants at its Hackensack, NJ location. This lupus nephritis clinical trial is actively enrolling qualified participants.

How do I join the lupus nephritis clinical trial in Hackensack?

To join this clinical trial in Hackensack, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Hackensack clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lupus Nephritis Clinical Trial in Hackensack, NJ

About This Lupus Nephritis Study in Hackensack

The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial. Treatment arms are (1) MMF dosed as per body-surface area (MMFBSA; 600mg/m2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of MMF (MMFPK; MMF dosed twice daily to achieve an area under the concentration-time curve (AUC0-12h) of MPA \>60-70 mg\*h/L. The study goal is to determine the safety and efficacy of MMFPK compared to MMFBSA for the treatment of prolifer

Sponsor: Children's Hospital Medical Center, Cincinnati

Who Can Participate

Inclusion Criteria

Male or female aged 8 to \< 21 years;

Must meet Classification Criteria for SLE as per the criteria of the American College of Rheumatology (ACR)/ European League Against Rheumatism

Diagnosed with proliferative LN as per the International Society of Nephrology/Renal Pathology Society4 based on kidney biopsy done within 90 days prior to enrollment into the study; Subjects may have been previously diagnosed with LN. For study inclusion, the kidney biopsy must be interpreted as one of the following classes: Class 3, Class 3/5, Class 4, or Class 4/5.

Treatment of LN with twice daily MMF as per the decision of the treating physician. The subject will have taken MMF as prescribed by their treating physician for a minimum of 4 days (or 8 doses).

Subject tolerates MMF as per the treating physician's opinion;

Able to swallow MMF tablets and capsules;

If subject is treated with belimumab, must be IV or SQ;

Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;

Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative/ parent(s)/legal guardian has been informed of all pertinent aspects of the study.

Parent or legal guardian must have a smart phone available and able to support the PLUMM smart phone application.

Must be able to complete study questionnaires in English or Spanish.

Exclusion Criteria

Perceived or stated inability to adhere to the study protocol;

Hypersensitivity to MMF or any component of the drug product;

Presence of features (from SLE or other chronic disease) that a-priori suggest that the subject benefits from other therapies than that suggested or allowable by the study protocol; These disease features include but are not limited to severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.

History of other kidney disease besides LN or prior to the diagnosis of SLE;

Need for renal replacement therapy within 2 weeks from Baseline Subjects can have required short-term renal replacement therapy prior to Baseline, for example due to preceding acute kidney injury.

Infections:

Untreated latent or active tuberculosis (TB);

Chronic infections requiring treatment;

A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B;

Diagnosis of any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within 4 weeks prior to Baseline visit;

Any treated infections within 2 weeks of Baseline visit;

History of infected joint prosthesis with prosthesis still in situ;

Blood dyscrasias, including:

Hemoglobin \<8.5 g/dL or Hematocrit \<22%;

White Blood Cell count \<2.6 x 109/L;

Neutrophil count \<1.2 x 109/L;

Platelet count \<100 x 109/L;

Lymphocyte count \<0.5 x 109/L.

8\) Estimated glomerular filtration rate \[GFR\] \<40 mL/min/1.73 m2 calculated using the CKiD U25 equation (see Appendix 4);

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal;

Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit;

History or current symptoms suggestive of lymphoproliferative disorders (e.g., Epstein Barr Virus \[EBV\] related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma);

Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ;

Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery;

Herbal supplements with pharmaceutical properties must be discontinued at least 1week prior to Baseline visit, unless there are sufficient data available regarding the duration of an herbal medication's pharmacokinetic and pharmacodynamic effects to allow a shorter or longer washout to be specified (e.g., 5 half-lives).

Oral or intravenous cyclophosphamide must be discontinued 12 weeks prior to Baseline visit

Use of prohibited prescription medication as listed in Appendix 3 within the specified time frame prior to Baseline visit

Participation in other studies involving investigational drug(s) within 4 weeks or 5 half-lives (whichever is longer) prior to Baseline visit and/or during study participation; Exposure to investigational biologics should be discussed with the Sponsor.

Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use two highly effective methods of contraception or are abstinent for the duration of the study;

Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hackensack?

Yes, this clinical trial (NCT05538208) has an active research site in Hackensack, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lupus Nephritis Treatment Options in Hackensack, NJ

If you're searching for lupus nephritis treatment options in Hackensack, NJ, this clinical trial (NCT05538208) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hackensack research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced lupus nephritis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lupus nephritis clinical trials near you to find additional studies recruiting in your area.

Lupus Nephritis Clinical Trial in Hackensack, NJ

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