Non-profit organization committed to improvement and dissemination of knowledge regarding the pathology and pathophysiology of renal disease

The Podo Trial

To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis

https://clinicaltrials.gov/ct2/show/NCT03448692

• Study Coordinator: Vickie Smith, RN
• Study Coordinator Email: vickiesmith@uabmc.edu
• Study Coordinator Phone: 1-800-718-1021
• Site Name: University of Alabama at Birmingham
• Address: 2000 6th Avenue South, Birmingham, AL 35233

• Sponsor: Pfizer Inc.
• Study DrugPF-06730512
• Estimated enrollment: 44
• Estimated end date: May, 2021

The FIRSTx Trial for FSGS Patients

https://clinicaltrials.gov/ct2/show/NCT03422510

• Study Coordinator: Tetyana Vasylyeva
• Study Coordinator Email: firstx-pms@umich.edu
• Study Coordinator Phone: 806-236-0320
• Site Name: Texas Tech University
• Address: 1400 Coulter St, Amarillo, TX 79106

• Sponsor: Complexa, Inc.
• Study Drug: CXA-10
• Estimated enrollment: 30
• Estimated end date: July, 2019

Liposorber Trial for FSGS in Children

https://clinicaltrials.gov/ct2/show/NCT02235857

• Study Coordinator: Rupesh Raina, MD; Samantha Formica, BSN, RN, CPN
• Study Coordinator Email: rraina@chmca.org ; sformica@chmca.org
• Study Coordinator Phone: 330-543-8950
• Site Name: Akron Children's Hospital
• Address:130 W. Exchange Street
• Sponsor: Kaneka Pharma America LLC

• Study Drug: N/A (device)
• Estimated enrollment: 35
• Estimated end date: October 2024

Pharmacokinetics and Pharmacodynamics of Apixaban in Nephrotic Syndrome

This study is to investigate the pharmacokinetics and pharmacodynamics of apixaban in adults with nephrotic syndrome.

Copy and paste this link into your browser: https://clinicaltrials.gov/ct2/show/NCT02599532

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Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

Vertex R&D APOL1- mediated kidney diseases

ClinicalTrials.gov Identifier: NCT04340362

Clinical trial description: https://clinicaltrials.gov/ct2/show/NCT04340362

Eligibility criteria

Ages Eligible for Study:	18 Years to 60 Years   (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

·         APOL1 genotype of G1/G1, G2/G2, or G1/G2

·         FSGS diagnosed by kidney biopsy

Key Exclusion Criteria:

·         Evidence of non-APOL1-mediated FSGS

·         Subjects with known sickle cell disease

·         Solid organ or Bone marrow transplant

Other protocol defined Inclusion/Exclusion criteria may apply.

Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared to the standard of care regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) in kidney transplant recipients.

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Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

The goal of this clinical trial is to determine whether abatacept us capable of decreasing proteinuria in patients with FSGS or Minimal Change Disease. For participants to be eligable, patients must have had a prior kidney biopsy with either diagnosis of FSGS ot MCD. Patients must also have failed or be intolerant of prior therapy for their kidney disease. The prior therapy must also have included include corticosteroids and at least one other drug. Participants will not be reqired to have another kidney biopsy and partiecipants must be over the age of 6.

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Ofatumumab in Children With Drug Resistant Idiopathic Nephrotic Syndrome

This is a double-blind, placebo-controlled randomized trial testing the superiority of Ofatumumab versus placebo in the treatment of children with Nephrotic Syndrome. Eligible participants will enter a 3-months run-in period, during which instructions on urine collection and dipstick readings will be carefully reviewed.

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Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor Dependent Idiopathic Nephrotic Syndrome

This clinical trial tests the superiority and efficiency of Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease remission in SD-INS. Eligible participants involve those who are between the ages of 2 and 24 who have been diagnosed with Nephrotic Syndrome and are in complete remission.

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A Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic Syndrome

This trial investigates the use of VPA (Valproic Acid) for the treatment of adult patients with biopsy proven idiopathic focal segmentel glomerulosclerosis (FSGS) or minimal change disease (MCD). VPA used as an add-on to steroids might induce clinical remission in a first category of patients and potentially reduce the dose of maintenance immunosuppression required to maintain remission afterwards.

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Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

In this study, researchers will evaluate the use of Acthar in patients with focal segmental glomerulosclerosis (FSGS) as they undergo renal transplantations. Researchers will then take note and measure the rate of FSGS recurrence.

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The pivotal DUPLEX Study is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled Phase 3 clinical trial evaluating the safety and efficacy of sparsentan for the treatment of FSGS

This is a randomized, double-blind study to determine the long-term nephroprotective potentional of treatment with sparasentan in comparison to an angiotensin receptor blocker. This study focuses on patients with primary focal segmental glomerulosclerosis (FSGS).

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Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

The purpose of this study it to investigate the potential therapeutic efficacy of Myfortic combined with low-dose corticosteorid as the first-line treament for minimal change nephrotic sndrome (MCNS). Patients will be assigned to either the standard-dose prednisolone monotherapy or the Myfortic combined with low-dose prednisolone treatment.

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Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease (MinTAC)

Minimal change disease (MCD) is a common cause of Nephrotic Syndrome for adults. The standard treatment for this starts with high doses of steroids. While effective in controlling Nephrotic Syndrome, it also has a high rate of side effects and causes long-term complications. Ths study is to compare the effectiveness of Tacrolimus (prog) versus prednisone for this with Nephrotic Syndrone, sectondary to MCD.

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Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS (PODOCYTE)

The purpose of this multiple dose study is to examine the effect(s) of H.P. Acthar® Gel (repository corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis (FSGS). This study pertains to those who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.

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Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome

The purpose of this study is to determine the hypolipidemic effect of Alirocumab when co-administered with atorvastatin compared to monotherapy with atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.

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Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Resistant Nephrotic Syndrome

While a vast majority of children with idiopathic nephrotic syndrom respond well to corticosteroid treatments, as many as 20% experience complications with steroid resistance (SRNS). The continuous use of these steroids in children causes long-term complications. The goal of this study is to determine if Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population.

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