CLINICAL RESEARCH

   Latest postings (last updated 3/27/2013): click the following links to learn more

• Phase 2 Clinical Study: Adult, Steroid Resistant Primary FSGS  
• Seeking participants with FSGS for telephone interview study - Compensation is $100  
• Clinical Trial for Membranous Nephropathy Patients  
• PROMIS: Nephrotic Syndrome Study for parents of children with NS 
• What do patients gain by participating in clinical trials?

For a full listing of nephrotic syndrome-specific clinical trials, please click here

Phase 2 Clinical Study: Adult, Steroid Resistant Primary FSGS- Compensation is provided

The purpose of this study is to find out how well and how safely Fresolimumab reduces the amount of protein in urine.  Increased protein in the urine is a common sign of FSGS.

 Fresolimumab is a human monoclonal antibody against Transforming Growth Factor Beta (TGF-beta).  TGF-beta is found naturally in the body and is involved in many biological processes, possibly including the development and progression of FSGS. Because of the possible role of TGF-beta in FSGS, using Fresolimumab to interfere with TGF-beta may help to reduce the severity or slow progression of this disease.

 Fresolimumab has already been tested in a limited number of patients with FSGS (16), as well as patients with a serious lung condition (25), and patients with skin and kidney cancers (29). Fresolimumab is investigational because it is not approved by the FDA (Food and Drug Administration) in the United States or a regulatory agency in any other country for treatment of FSGS.

For more information about the study or to ask where a study research center will be opening near you, contact:

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665391 and mention that you learned of the study on the NephCure website.

Seeking participants with FSGS for telephone interview study

Health Outcomes Solutions (HOS), a health outcomes research organization, is gathering information from individuals with focal segmental glomerulosclerosis (FSGS). Eligible participants will be asked to complete and return a brief questionnaire and to share opinions in a telephone interview. Compensation is $100.

To participate in this research study, you must:

1.  Be between the ages of 18 and 65 years of age
2.  Have a diagnosis of primary idiopathic FSGS
3.  Have been diagnosed with FSGS between 3 and 36 months ago
4.  Previously failed no more than 2 treatments for FSGS
5.  Be willing to take part in one telephone interview lasting no more than 1 hour
6.  Be willing to allow HOS to contact your doctor to obtain additional information about your           condition and treatment

Clinical information will also be collected from your health care provider that knows the most about your FSGS. So if you participate in this interview study, HOS would need to contact that individual.

This study has received approval by a formal Ethics Committee/IRB. All of the information provided will be absolutely confidential. Please click on the link below to complete the screening survey and to provide consent to participate in the telephone interview study.

To participate, click here: https://www.surveymonkey.com/s/FSGS. 

If you are eligible you will be contacted within 3-5 days.

Enrollment into the study is limited, so if you would like to participate, please act quickly.

Clinical Trial for Membranous Nephropathy Patients:

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of H.P. Acthar Gel (Acthar) in Treatment-Resistant Subjects With Persistent Proteinuria and Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy (iMN)

Eligibility for Study: Men & Women ages 18 years to 75 years with a history of nephrotic syndrome due to idiopathic Membranous Nephropathy as confirmed by documented result from a renal biopsy.

Click here for more information and complete list of inclusion and exclusion criteria

Older postings :

PROMIS: Nephrotic Syndrome Study

Childhood onset nephrotic syndrome occurs when the kidneys leak large amounts of protein into the urine. Nephrotic syndrome is a disease that can be persistent, improve (remission) or cycle between remission and active (relapse) periods. The purpose of this study is to learn how your child feels when he or she has active nephrotic syndrome as compared to when he or she is in remission. Your child will complete an internet based survey at 3 different times in a single year. The survey will ask how he or she feels during daily activities at home and at school.

To take part in this study your child must have nephrotic syndrome and be between 8 and 17 years old. He or she needs to be able to read English. Enroll in this study here: PROMIS

What do patients gain by participating in clinical trials?

• Actively participate in their health care
• Obtain access to new treatments before they are widely accessible
• Help others by contributing to the progression of medical research

Before the FDA can approve a therapy, 3 phases of study must be successfully completed:

Phase 1: The treatment is administered to a small group of people (about 20-80) to assess the safety, determine a dosage range, and detect any possible side effects.

Phase 2: A larger group of about 100-300 people receive the treatment to examine its effectiveness and further assess its safety.

Phase 3: The treatment is administered to an even larger group of 1,000- 3,000 to verify its usefulness, monitor side effects, compare it to existing treatments, and obtain more information to insure that the treatment is used safely.