Title of Trial: A randomized, Multicountry, Mulitcenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy SONAR: Study of Diabetic Nephropathy with Atrasentan.
WIRB Protocol Number: 20131336
NCT#: 01858532
PI Name: Dana Rizk, MD
Contact: Teresa Chacana. Phone number 205-934-7649
Status of the trial: Enrollment Closed

Brief Description: This study is being conducted to evaluate the effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy.

The study will evaluate the effect of Atrasentan compared with placebo on time of doubling of serum creatinine or the onset of the end stage renal disease (ESRD) in subjects with type 2 diabetes and nephropathy who are treated with the maximum tolerated labeled daily dose of a Renin-Angiotensin System (RAS) inhibitor. In addition, the study will assess the effects of atrasentan compared with placebo on cardiovascular morbidity and mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR), as well as on the impact on quality of life in subjects with type 2 diabetes and nephropathy.

This study requires several visits to UAB. Some of the procedures are: electrocardiogram, collect: a blood sample, a urine sample and a DNA sample. Atrasentan or placebo will be provided at no cost for the subject participating in the study. Compensation is $50.00 per visit


Title of Trial: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease.
WIRB protocol Number:  20151757
NCT#:  02540993
PI Name: Eric Judd, MD
Contact: Laura Latta (205) 975-8638 or alatta@uabmc.edu
Status of the trial: Enrolling

Brief Description:  The purpose of this study is to investigate the efficacy and safety of finerenone, a new drug under development (not approved by the FDA), compared with the current standard treatment for diabetic kidney disease (DKD).  Compensation is $85.00 per completed visit.

Key inclusion criteria:
∙Men or Women ≥18 years of age
∙Diagnosed Diabetes Mellitus Type II 
∙Diagnosis of CKD with persistent High or Very High Albuminuria.
∙eGFR >25mL/min/1.73m²
∙Treated with ACE or ARB (Max Tolerated Dose)
∙Serum Potassium <4.8 mmol/L
Key Exclusion criteria:
∙HbA1c > 12%.
∙UACR>5000 mg/g
∙Uncontrolled arterial hypertension  SBP >170mmHg or DBP >110mmHg
∙CHF with reduced ejection fraction (HFrEF)
∙Clinical evidence with stroke, TIA, ACS in past 30 days.
∙Dialysis for acute renal failure within 12 weeks
∙Addison’s disease



Title of Trial: “GDCN Clinical Center: Advancing Clinical Research in Primary Glomerular Diseases [Cure Glomerulonephropathy Network (CureGN)]”
Sponsor:  NIH and NIDDK
IRB or WIRB Protocol Number: X140723006
UAB PI Name: Bruce A. Julian, MD, Dana V. Rizk, MD
Contact: Courtany Grammer, BS,

Phone number: 205-996-0095, Email: courtanygrammer@uabmc.edu, fax number: 205- 996-7735

Status of the trial: Enrolling
Criteria:

  • Inclusion:
    • Male and female subjects, age ≥ 18 years with one of the following glomerular diseases (diagnosis must be biopsy proven within five years prior to enrolment):
      • Membranous Nephropathy
      • IgA Nephropathy
      • Minimal Change Disease
      • Focal Segmental Glomerulosclerosis
    • Exclusion:
      • Diagnosis of any of the following at the time of Biopsy:
        • Diabetes
        • Lupus
        • End stage renal disease
        • Active malignancy, except for non-melanoma skin cancer
        • HIV
        • Hepatitis B
        • Hepatitis C
  • Brief Description: The major goal of this project is to recruit and retain at least 600 patients with each of four kidney diseases (minimal-change disease, focal segmental glomerulosclerosis, membranous nephropathy and IgA nephropathy) willing to participate in longitudinal cohort studies and disease-specific research initiatives to explore critical clinical and scientific questions that will improve understanding of disease pathogenesis and improve the quality of care and life for patients with these glomerular diseases.

Title of Trial: “Elucidating IgA Nephropathy through Genetic Studies of IgA1 Glycosylation”.
Sponsor: NIH and NIDDK
IRB or WIRB Protocol Number: X090713001
PI Name: Bruce A. Julian, MD, Jan Novak, PhD
Contact: Courtany Grammer, BS,

Phone number: 205-996-0095, Email: courtanygrammer@uabmc.edu, fax number: 205- 996-7735

Status of the trial: Enrolling

  • Brief Description: This study will test the hypothesis that a high level of serum Gd-IgA1 defines an endophenotype that can be used to identify the genetic basis for the aberrant glycosylation of IgA1, and thus the genetic basis of IgA nephropathy.

Title of Trial: “IgA Nephropathy: Interventions with Generation of Nephritogenic Immune Complexes”.

Sponsor: NIH
IRB or WIRB Protocol Number:  X140108002
PI Name: Bruce A. Julian, MD, Jiri Mestecky, MD, Jan Novak, PhD
Contact: Courtany Grammer, BS,

Phone number: 205-996-0095, Email: courtanygrammer@uabmc.edu, fax number: 205- 996-7735

Status of the trial: Enrolling

  • Brief Description: This proposal will test the proof of the concept that non-cross-linking, single-chain, antibodies directed against the galactose-deficient region of some of the IgA1 antibody in the circulation can block formation of large immune complexes that damage the kidney in patients with IgA nephropathy. 

Title of Trial: “Molecular Basis of Pathogenicity of IgA1-containing Immune Complexes”.

Sponsor: NIH, NIDDK/NIAID
IRB or WIRB Protocol Number:  X070413006
PI Name:  Bruce Julian, MD, Jan Novak, PhD

Contact: Courtany Grammer, BS,

Phone number: 205-996-0095, Email: courtanygrammer@uabmc.edu, fax number: 205- 996-7735

Status of the trial: Enrolling

  • Brief Description: The goal is to provide an improved understanding of the role of aberrant glycosylation of IgA1 in the formation of immune complexes in IgA nephropathy.

Title of Trial: “Renal Imaging to Assess Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD):  Extension (CRISP III) (PID, Innovative Imaging to Assess Progression (PCC))”.
UAB IRB Protocol Number: F110901006
NCT#: 01039987
PI Name: Michal Mrug, MD
Contact: Teresa Chacana, MSN, RN. Phone number: 205-934-7649, tchacana@uab.edu, fax 205-975-0814
Status of the trial: Enrolling by invitation

Brief Description: The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD defined as a change in both renal and renal cyst volumes and renal function over time. Subjects enrolled in the initial CRISP study are invited to continue participation in the succeeding CRISP studies.

This study requires four annual visits to UAB. Some of the procedures are: physical exam by MD, MRI of kidneys, collect blood and urine sample. There is compensation for travel expenses and two annual visits.


Title of Trial: “A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease”.

Sponsor Protocol: 156-13-211
WIRB Protocol Number: 20141519
NCT#: 02251275
PI Name: Michal Mrug, MD
Contact: Amy Bottomlee, RN. Phone number: 205-975-4482, amybottomlee@uabmc.edu, fax 205-996-0275
Status of the trial: Enrollment closed

Criteria: Male and female subjects, age ≥ 18 years with confirmed diagnosis of ADPKD (during participation in prior Tolvaptan trials) who have:
•             Completed and transferred from the double-blind Trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment), or
•             Completed Trial 156-08-271 or a prior tolvaptan trial, or
•             Interrupted or discontinued treatment in a prior tolvaptan ADPKD trial other than Trial 156-13-210. Subjects may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the study.

Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m2 within 45 days of the baseline visit. Subjects who have an eGFR between 15 and 19 mL/min/1.73m2 may be enrolled with medical monitor approval
Brief Description: This trial is a phase 3b to evaluate and describe the long-term safety of Tolvaptan treatment in ADPKD patients with CKD (chronic kidney disease). Eligible Subjects will enter the trial from Trial 156-08-271 or other Tolvaptan interventional trials. Renal function will be assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR). General safety endpoints will be assessed and also relevant safety endpoints for the trial as serum transaminase elevations in frequency & serum sodium excursions.

This study requires several visit to UAB. Some of the procedures are: physical exam by MD, collect blood and urine sample.  Tolvaptan will be provided at no cost for the subject participating in the study. Compensation is $75.00 per visit.


Title of Trial:  Cardinal “A Phase 2/3 Trial of the efficacy and safety of Bardoxolone Methyl in patients with Alport Syndrome”.

Sponsor Protocol: 402-C-1603
WIRB Protocol Number: 20162760
NCT#: 03019185
PI Name: Dana Rizk, MD
Contact: Amy Bottomlee, RN. Phone number: 205-975-4482, amybottomlee@uabmc.edu, fax 205-996-0275
Status of the trial: Currently enrolling

Key Eligibility Criteria:
Male and female subjects,  18 -60 years with confirmed diagnosis of Alport Syndrome who have:
∙             Screening eGRF ≥ 30 and ≤90
∙             Albumin to Creatinine ratio ≤ 3500mg/g
∙             no current hemodialysis or peritoneal dialysis, no history of renal transplant or uncontrolled diabetes, no heart disease

The primary study objective in Cardinal is to evaluate the effect of bardoxolone methyl on estimated glomerular filtration rate (eGFR) in patients with Alport Syndrome.  Genetic testing provided.  This is a 2 year study with several visits to UAB which may require a physical exam, and blood/urine collection.  Compensation is provided.

Title of Trial:  “Multicenter, Double-Blinded, Placebo-Controlled Study of PRT-201 Administered Immediately after Radiocephalic Arteriovenous Fistula Creation in Patients with Chronic Kidney Disease”
WIRB Protocol Number: 20140905
NCT#: 02110901
PI Name:  Timmy Lee, MD
Contact:  Rebecca Womack.  Phone number 205-975-0549, rwomack@uab.edu, fax 205-975-8879
Status of the trial:  Enrollment Complete

Brief Description:  This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF).

The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.


Title of Trial: “Multicenter, Double-Blind, Placebo-Controlled Study of Vonapanitase (PRT-201) Administered Immediately after Radiocephalic Arteriovenous Fistula Creation in Patients with Chronic Kidney Disease
WIRB Protocol Number: 20150988
NCT#: 02110901
PI Name: Timmy Lee, MD
Contact: Rebecca Womack.  Phone number 205-975-0549, rwomack@uab.edu" href="https://www.uab.edu/medicine/nephrology/rwomack@uab.edu">rwomack@uab.edu, fax 205-975-8879
Status of the trial: Enrolling

Brief Description: This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase in patients whoe have chronic kidney disease and who are undergoing surgery to create a new access to their bloodstream for hemodialysis. An experimental drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). 206 patients with chronic kidney disease have been administered vonapanitase in previous studies sponsored by Proteon Therapeutics. In those studies, vonapanitase is called PRT-201. In previous research studies vonpanitase has been shown to help keep vessels open when applied to the outside surface of the blood vessels (arteries and veins) in patients that undergo surgery to create an AVF. Purpose of the study is to determine whether vonapanitase is well tolerated and can keep the blood vessel open (improve patency) of your AVF when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery.

This study requires 8 visits to UAB. Some of the procedures are to collect: physical exam by MD, Ultrasound and blood samples. Compensation is $50.00 per visit.

Title of Trial: “Biological characterization of acute kidney injury in patients in the intensive care unit.”
UAB IRB#: F120507002
NCT#: None
PI Name: Ashita Tolwani, MD/UAB O’Brien Center
Contact: Laura Latta (205) 975-8638 or alatta@uabmc.edu
Status of the trial: Screening/Enrolling eligible In-Hospital ICU Patients meeting strict criteria.

Brief Description: The purpose of this study is to collect biological samples in critically ill patients before and after the development of kidney injury.  This study will examine the effectiveness of different laboratory tests for the diagnosis of kidney injury and for predicting recovery from the injury.

 

Title of Trial: Normal Ranges of Biomarkers of Kidney Injury in a Healthy Population
UAB IRB#:  X120824004

NCT#: None
PI Name: Ashita Tolwani, MD/UAB O’Brien Center
Contact: Laura Latta (205) 975-8638 or alatta@uabmc.edu
Status of the trial: Enrolling Healthy volunteers

Brief Description:  The purpose of this study is to obtain a pool of normal control subjects to generate normal range values of novel biomarkers for Acute Kidney Injury and the correlation with microcirculation. 


Title of Trial: “Impact of lowering phosphate additive intake on mineral metabolism and cardiovascular health in community-living adults (Phosphate and FGF23:  Dietary and Molecular Mediators of health Disparities in Cardiovascular and Kidney Diseases)”
UAB IRB Protocol Number: F150728005                                
PI Name: Orlando Gutiérrez, MD
Contact: Alexandra McPherson. Phone number: 205-975-9743, alexlm@uab.edu
Status of the trial:  Enrolling

Criteria: To be considered for this study individuals should be healthy, older than 19 years old, BMI under 35, non-smokers and pass the phone screening.

Brief Description: The purpose of this study is to examine the effects of food additives on blood levels of phosphorus, FGF23, and blood vessel health in healthy individuals. This study will enroll 50 participants in total. 

This study requires seven visits to the Clinical Research Unit at UAB and follow a meal plan for two months, also blood samples, and urine samples.  Compensation is $400.00.