Clinical Trials and Research

 

AAKP's role in Clinical Trials and Market Research

AAKP supports innovation in the kidney space. We are actively involved in market research - to share the patient voice and experience with renal companies and clinical trials  - to create more and better treatment options for kidney patients, so they can achieve their aspirations.

You may have heard the term “clinical trials” but wonder what that means. Is a clinical trial something you can participate in? What do you need to do to get started? We have pulled together some information that you might find helpful as you decide whether you would like to participate in a clinical trial.

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Clinical Trials and Market Research Opportunities

Below is a list of the Clinical Trials and Market Research opportunities that AAKP is partnering to raise awareness of.  You can also use the search tool below to be matched to even more opportunities.

Name Description Learn More
KYSA-1 The KYSA-1 trial is designed to evaluate if Chimeric Antigen Receptor (CAR) T-cell therapy is safe in people who have active lupus nephritis (LN) and do not get better with standard therapies. CAR T-cell therapy is a type of treatment called immunotherapy. This means it works with your immune system to target B cells in your body. Unhealthy B cells drive inflammation and disease activity in LN. Click here to read more about this opportunity.
SAFE Kidney II The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BK viremia and progression to biopsy-confirmed BKVAN in Kidney Transplant Recipients (KTRs). The study includes two parts. The phase II part will evaluate the safety of AntiBKV in KTRs and establish proof of concept. The phase III part will assess the efficacy of AntiBKV in KTRs. Click here to read more about this opportunity.
SUPERNOVA SUPERNOVA is a pivotal Phase I/III trial for AZD3152, a next-generation long-acting antibody developed to protect vulnerable patients, such as the immunocompromised, from COVID-19. Click here to read more about this opportunity.
KICK Study The KICK Study is a clinical trial testing oral difelikefalin to see if it helps reduce the intensity of itching and the impact that itching has on your quality of life. The oral form of difelikefalin is considered an investigational drug at this time because that form of medication has not been approved by the FDA. An intravenous (IV) form of difelikefalin has been approved by the FDA to treat itching associated with CKD in adults who are undergoing dialysis. The KICK Study will evaluate the medication in its oral (tablet) form to see if it reduces the itching in CKD patients. To be eligible for the study, patients must have advanced CKD (stage 4-5) and experience at least moderate level of itching. Click here to read more about this opportunity.
ConfIdeS Protocol 20-HMedIdeS-17/ ConfIdeS: An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care. The study is for End-Stage Renal Disease (ESRD) patients that are highly sensitized and are active on the OPTN waiting list for a kidney transplant. Click here to read more about this opportunity.
VALIANT The VALIANT study is enrolling young people and adults who have C3G or MPGN to evaluate the safety and effectiveness of an investigational, targeted C3-inhibitor called pegcetacoplan. This study will assess whether the investigational medication has an effect on the damage to kidney function that is caused by build-up of the complement protein C3 in the kidney. To be eligible for the study, participants must be at least 12 years old and be diagnosed with C3G or MPGN. Additional criteria will be assessed at the research site to confirm eligibility. All study-related procedures and study medication will be provided to participants at no cost. Transportation to and from study visits, or reimbursement for travel-related costs may be available to study participants. Click here to read more about this opportunity.
AFFINITY Study The AFFINITY Study is an open-label, phase 2 study evaluating an investigational medication called atrasentan in patients with immunoglobulin A nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), Alport syndrome, and diabetic kidney disease (DKD). The goal of the AFFINITY Study is to understand whether atrasentan can lower the amount of protein in the urine and slow the decline of kidney function in patients. Approximately 80 patients will receive atrasentan by mouth for 52 weeks. Virtual trial options may include telemedicine and home health nurse visits. Click here to read more about this opportunity.
Kibow Pharmaceuticals (Phase 2B study of US- APR 2020) The purpose of this study to evaluate the safety and efficacy of an investigational medication in individuals with chronic kidney disease stage 4. This purpose of this FDA-approved Investigational drug is to determine safety and its ability to reduce or slow progression of patients who have been diagnosed with CKD stage 4 and how it impacts on their quality of life. Click here to read more about this opportunity.
TRACTION-2 Study The TRACTION-2 clinical research trial is evaluating an investigational product called GFB-887 for the potential treatment of focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), and diabetic nephropathy (DN). The purpose of the trial is to determine if GFB-887 is safe and may help people who have high levels of protein in their urine due to their kidney disease. Click here to read more about this opportunity.
InnAVasc Arteriovenous Graft Technology If you have kidney failure and are currently undergoing hemodialysis or are expected to require hemodialysis, you may be a candidate for a clinical study evaluating the InnAVasc Arteriovenous Graft – an investigational graft that may make the graft easier to locate under your skin, safer to stick for dialysis, more durable, less likely to bleed after your dialysis session when compared to standard care grafts, and allows for immediate use to reduce catheter time. Click here to read more about this opportunity.
TruGraf Long Term Clinical Outcomes Study The purpose of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes. Click here to read more about this opportunity.
Emerald Study Ongoing Pediatric Clinical Trial. Parents – do you have a child between the ages of 2 and 12 with kidney disease who also struggles to manage high blood potassium levels? Click here to read more about this opportunity.

 

 

 



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