Current Projects
3D Splint: A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable
Tracheobronchial Splint in Pediatric Subjects with Clinically Significant Tracheobronchomalacia
Principal Investigator: Richard Ohye, MD
Sponsor: University of Michigan
This device trial seeks to demonstrate the safety and effectiveness of the Materialise
Bioresorbable Tracheobronchial splint device in 35 pediatric patients (greater than
1 week and less than 4 years of age) with clinically significant tracheobronchomalacia
(TBM). TBM is a condition of dynamic collapse of the trachea or bronchi during respiration,
and leads to a wide array of respiratory symptoms, which can range from a chronic
cough and/or wheezing with vigorous activity to life-threatening airway obstruction.
Currently, the most severe forms of TBM lack adequate intervention. The Bioresorbable
Tracheobronchial Splint was originally developed at the University of Michigan, and
in December 2015, the airway splint Intellectual Property was licensed to Materialise;
Materialise has since taken over further development of the device. The primary endpoints
of the study are short-term patency (4+/-2 weeks post splint implantation) as measured
by CT scan and safety/survival to six months post-splinting. SABER provides project
management, clinical monitoring, and data management for this study.
ATHENA: A Phase II, Randomized, Double-Blind, Safety and Efficacy Study of Tiprelestat
Versus Placebo when Added to Standard of Care for the Treatment of Pulmonary Arterial
Hypertension (PAH)
Principal Investigators: Marlene Rabinovitch, MD; Roham T Zamanian, MD, FCCP
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
This randomized, double-blind, placebo-controlled Phase 2 trial will randomize 90
participants across 10 sites with pulmonary arterial hypertension (PAH) to 32 weeks
of either tiprelestat (recombinant human Elafin) or placebo. The primary objective
is to compare the efficacy (as measured by pulmonary vascular resistance [PVR]) of
tiprelestat plus Standard of Care (SOC) compared with placebo plus SOC in patients
with WHO functional class II-IV PAH. SABER is the DCC for this trial and will provide
project management, data management, clinical monitoring, software development, and
statistical analysis for the clinical trial.
AWARE: Autism With ADHD Research on Efficacy
Principal Investigator: Daniel Coury, MD
Sponsor: PCORI
The overall goal of the proposed study is to determine the relative effectiveness
of the most commonly prescribed FDA approved medications for the treatment of ADHD
in a specific population, children and adolescents with ASD. It is unclear whether
the guidelines previously developed for the treatment of ADHD in children with ASD
(largely based on guidelines for TD children) is appropriate or whether new guidelines,
specific to the ASD population, need to be developed. This naturalistic, pragmatic
clinical trial will use a multicenter SMART (Sequential Multiple Assignment Randomization
Trial) design to help resolve this controversy.
ChiLDReN: The Childhood Liver Disease Research and Education Network
Principal Investigator: John Magee, MD
Sponsor: National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
ChiLDReN is a network of 15 clinical sites conducting clinical trials and cohort studies
of children with rare liver diseases. The ChiLDReN Network was developed to support
the discovery of new diagnostics, etiologic, and treatment options for children with
liver disease, and those who undergo liver transplantation. SABER partners to provide
statistical analysis, clinical monitoring, project management, and clinical research
administration to support this series of studies.
Citalopram: Citalopram as a Posterior Cortical Protective Therapy in Parkinson’s Disease
Principal Investigator: Vikas Kotagal, MD, MS
Sponsor: National Institute of Aging (NIA)
Citalopram is a 5-year proof-of-concept Parkinson disease clinical trial aimed at
delaying visuospatial cognitive decline, a critical component of Parkinson disease
dementia. This is a single-site, phase 2, double-blind, and placebo-controlled study.
Participants with Parkinson disease will be enrolled in the study for 28-months,
and will receive either 20mg of citalopram daily, or matching placebo. They will
undergo PET and MRI imaging, as well as cognitive and clinical testing. SABER is
the DCC for this project and will provide project management, data management, software
development, and statistical analysis.
CRANE: Reducing falls with Varenicline in Hypocholinergic Parkinson Disease
Principal Investigators: Vikas Kotagal, MD, MS; Roger Albin, MD
Sponsor: NINDS
This early-phase single-site double-blind parallel group trial will randomize 76 participants
with Parkinson disease-Mild Cognitive Impairment (PD-MCI) and evidence of low brain
cholinergic integrity on brain fluoroethoxybenzovesamicol (FEOBV) Positron Emission
Tomography (PET) to 12 months of either varenicline or placebo. The primary endpoint
is change from the time of in-person screening to month 12 in “normal pace-dual task
cost" (npDTC). Secondary and exploratory outcomes will examine varenicline’s effect
on fall frequency, including a novel composite of falls, near-falls, and fall related
injury. SABER is the DCC for this trial that provides project management, data management,
and statistical analysis services.
CTR Launch: Comparing Protocol Writing Services with Protocol Writing Consultation
to Improve the Quality of Clinical Trial Protocol Documents
PI: Anna Lok, MD
Sponsor: National Center for the Advancement of Translational Science (NCATS)
This study is a single-center, randomized controlled investigation of two protocol
writing support services: protocol writing support (PPS) vs. protocol writing templates
and brief consultation (PTC) for University of Michigan study teams of single-site
investigator-initiated trials (IIT) of behavioral, drug, biologic, and device therapies.
Eligible IITs will be randomized 1:1 to either PPS or PTC, stratified by behavioral
vs. drug, biologic, or device trial therapies. The CTR-Launch study team and PI of
the randomized IIT and their study teams will be unblinded to study intervention;
however, the members of the Protocol Quality Rating Team will be blinded to study
strategy and trial PI. In addition, eligible IITs from PIs who do not agree to be
randomized will be assigned to a “no intervention, not randomized” (NINR) group and
receive neither PPS nor PTC. Protocol quality and other outcomes will be assessed
for these protocols.
DEPTH: Doxycycline for Emphysema in People Living with HIV
Study PIs: Robert Kaner, MD, Marshall Glesby, MD, and Cathie Spino, ScD
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
DEPTH (Doxycycline for Emphysema in People Living with HIV) is a phase 2, multicenter,
randomized, double-blinded, placebo-controlled clinical trial. Based on randomization,
participants will receive 100 mg doxycycline BID or placebo for 72 weeks. The primary
objective is to determine if doxycycline reduces progression of emphysema relative
to placebo as measured by rate of decline (slope) of present predicted diffusing capacity
for carbon monoxide (DLco) corrected for hemoglobin, carboxyhemoglobin, and barometric
pressure (indicated as ppDLcoadj) over the 72-week treatment period. SABER is the
DCC for this project and will provide project management, data management, clinical
monitoring, software development and statistical analysis for the clinical trial.
DFC: Diabetic Foot Consortium Data Coordinating Center (DCC)
Principal Investigator for DCC: Cathie Spino, ScD
Sponsor: National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
The Diabetic Foot Consortium (DFC) is a network of 4 clinical sites, 3 satellite sites,
several biomarker analysis units, and the data coordinating center (DCC) that will
conduct studies to validate biomarkers for diabetic foot ulcers. Future studies may
expand to include clinical trials. SABER is the DCC for this consortium and provides
the project management, data management, clinical monitoring, software development,
and statistical reporting and analyses for the following consortium studies:
- Open DFU Master Protocol This study is a platform study designed to efficiently test multiple biomarkers to
identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not
healing that ultimately could be applied at the point of care to drive personalized
management decisions, and to better inform clinical trials of wound healing interventions.
The platform study is designed to be flexible so that it is suitable for a wide range
of studies relevant to patients with open (active) DFUs. This platform study will
enroll patients with DFUs seen in an outpatient setting in diabetic foot and wound
care clinics across a range of healthcare systems, including community settings and
tertiary care hospitals, participating in the DFC. SABER is the DCC for this project
and will provide project management, data management, software development, and statistical
analysis.
- STATUS: First subject enrolled June 29th, 2023. In enrollment and follow-up.
EGCG: Dose Ranging Study of Oral Epigallocatechin-3-Gallate (EGCG) Given Daily For
12 Weeks to Patients with Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK
Interactions with Standard of Care Drugs, and Biomarkers of Drug Effect.
Principal Investigators: Harold A. Chapman, MD, Fernando J. Martinez, MD, MS, and
Cathie Spino, ScD
Sponsor: UCSF
The EGCG study is a multi-center, double-blind, placebo-controlled, dose-ranging phase
1 study looking at EGCG safety in idiopathic pulmonary fibrosis (IPF) patients. This
interventional study will test whether a low cost and largely non-toxic small molecule,
purified from green tea, EGCG, is safe when given daily to IPF patients over 12 weeks
with their IPF drugs, nintedanib and pirfenidone, and the pharmacokinetic interactions
of EGCG with these standard of care anti-fibrotic drugs. SABER is the DCC for this
project and will provide project management, data management, clinical monitoring,
software development, and statistical analysis for the clinical trial.
LowSalt4Life 2: A Just-In-Time Adaptive Mobile Application Intervention To Reduce
Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life
Principal Investigator: Brahmajee Nallamothu, MD and Michael Dorsch, PharmD, MS
Sponsor: The National Heart, Lung, and Blood Institute (NHLBI)
The LowSalt4Life study is a single center, 6-month sequential prospective randomized
controlled clinical trial. This study will investigate the effectiveness of a contextual
just-in-time adaptive intervention (JITAI) delivered via a mobile app for hypertension
patients. The dietary sodium intervention promotes lower sodium intake. Eligible participants
will be randomized to the mobile application with a JITAI (App+JITAI) or the mobile
application content alone (App alone) in a 1:1 manner and followed for 2 months, stratified
by recruitment pool and gender. After 2 months, the App+JITAI group will be further
randomized to continuing the App+JITAI or App+optimized JITAI in a 1:1 manner. The
primary outcome is change in systolic blood pressure (SBP) at 2 months. Secondary
outcomes include changes in BP medication, dietary sodium intake, and engagement metrics.
SABER provides statistical analysis for this study.
LYNC-LD: Lipodystrophy Syndromes to Determine Prevalence, Incidence and Predictors
of Diabetes and Severe Hypertriglyceridemia, and their Complications
Principal Investigator: Elif Oral, MD
Sponsor: Originally funded by Aegerion Pharmaceuticals. Now funded by Lipodystrophy
Research Fund established at the University of Michigan.
LYNC-LD is a prospective multicenter natural history study of lipodystrophy syndromes
to determine the prevalence, incidence and predictors of diabetes and severe hypertriglyceridemia,
and their complications. This is an international, multicenter, prospective registry
study of patients with lipodystrophies to define true prevalence estimates and document
a thorough snapshot of the natural history of lipodystrophies in the contemporary
era. Approximately 500 participants will be enrolled with all forms of lipodystrophy
syndromes. Their participation will last approximately 4 years while we collect robust
clinical, metabolic, morbidity, and mortality data. The primary aim is to determine
the natural history of common metabolic complications of lipodystrophy syndromes,
including diabetes mellitus and severe hypertriglyceridemia (fasting serum TG ≥ 500
mg/dL) in various subtypes of lipodystrophy syndromes, and to determine the incidence
rates of clinical outcomes related to these metabolic complications in participants
without these complications at baseline and describe the predictive value of their
baseline characteristics for the these clinical outcomes. SABER is the DCC for this
project and will provide project management, data management, and statistical analysis
for this clinical trial.
MAP COPD: Michigan eArly disease Progression cohort in COPD
Investigators: MeiLan Han, MD, MS, Wassim Labaki, MD, MS, Jeffrey Curtis, MD, and
Craig Galban, PhD
Sponsors: Taubman Institute and COPD Foundation
Michigan eArly disease Progression cohort in COPD (MAP COPD) is an observational study
looking to gather new knowledge regarding screening for COPD and to understand the
burden of early COPD disease in patients. The aim of this study is to develop a disease
progression cohort within the University of Michigan Health System to capture pulmonary
function, symptom assessments and quantitative imaging among patients at risk for
or with an established diagnosis of COPD, focusing however on “early” COPD (age 30-60
and GOLD stage 0,1 and 2). Once the cohort is established, these data can subsequently
be used to (a) understand how to identify this patient population within a health
system and describe their symptom, exacerbation, radiologic and comorbidity burden;
(b) collect longitudinal information to understand disease trajectory in this unique
patient population; and (c) leverage this highly characterized patient pool for subsequent
therapeutic clinical trials. Ultimately, creation of this cohort at the University
of Michigan would establish a model that could be applied within other health systems
for establishing pools of well characterized, early-stage patients at risk for disease
progression to be leveraged for future studies.
PFF Community Registry
PI: Dr. Kevin R. Flaherty
Sponsor: Pulmonary Fibrosis Foundation
Pulmonary fibrosis (PF) results from a diverse group of health conditions and affects
the lives of patients (including those who are post lung transplant), caregivers and
family members. The Pulmonary Fibrosis Foundation Community Registry is an observational,
longitudinal cohort study that offers an online portal where participants can self-enroll
and directly contribute information about their experience with PF by answering a
series of surveys at regular intervals to be compiled into a longitudinal data set
for use by researchers. The PFF Community Registry enrolls three different cohort
groups:
- Patients with PF, including those who are post lung transplant
- Caregivers of patients with PF
- Family members of patients with PF.
This is an online registry open to individuals affected by PF in the US. It is not associated with a physical location or institution
PFF-R: Pulmonary Fibrosis Foundation Registry and Biorepository
Principal Investigator: Cathie Spino, ScD
Sponsor: Pulmonary Fibrosis Foundation
The PFF Patient Registry is a prospective collection of data, biospecimen, and HRCT
images from 2,000 patients with Interstitial Lung Disease (ILD) from over 40 Pulmonary
Fibrosis Foundation Care Center Network sites across the United States. ILD describes
a diverse group of conditions where, in general, the lung tissue becomes thickened,
stiff, and scarred (pulmonary fibrosis). The registry was active from 2016-2022, during
which coordinators abstracted clinical data and collected Patient Reported Outcomes
(PROs) every six months. These data are currently available to researchers to advance
our knowledge about this disease.
SABER provided project and data management while the registry was open, and now provides statistical analyses, based on this collection of data, for 8-12 ancillary studies per year which are proposed by interested researchers.
PRECISIONS: Prospective Treatment Efficacy in IPF Using Genotype for NAC Selection
Data Coordinating Center (DCC) Principal Investigators: Cathie Spino, ScD and Kevin
Flaherty, MD, University of Michigan
Clinical Coordinating Center (CCC) Principal Investigators: Fernando Martinez, MD,
Weill Cornell, and Imre Noth, MD, University of Virginia
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
PRECISIONS is a 6-year project which utilizes the Pulmonary Fibrosis Foundation Registry
and Biorepository (see separate entry on this page) to perform a whole genome sequencing
and proteomic analysis of around 1,400 people with interstitial lung disease. As
a proof of concept of how this data can be utilized to create a more precise approach
to medicine, the project includes a large double-blind, placebo-controlled, randomized
trial that will determine if people with idiopathic pulmonary fibrosis (IPF) who have
the TOLLIP rs3750920 TT genotype will benefit from the use of N-acetylcysteine (NAC)
in addition to standard of care for IPF. SABER is the DCC for this project and will
provide project management, data management, clinical monitoring, software development,
and statistical analysis for the clinical trial.
PRIME PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary
Fibrosis (PRIME-PPF)
Principal Investigator: Fernando Martinez
Sponsor: University of Massachusetts, Worcester
PRIME PPF is a prospective, observational cohort study where 500 participants with
non-idiopathic pulmonary fibrosis (non-IPF) fibrosing interstitial lung disease (ILD)
will be recruited at approximately 40 centers across the United States and globally
then provided follow up assessments for 24 months . The primary objective is to optimize
progressive pulmonary fibrosis (PPF) classification and establish PPF incidence for
key ILD subtypes. Additional exploratory objectives are to 1) Prospectively validate
a novel PPF classifier and assess performance durability over time, and 2) Determine
whether multi-dimensional PPF prediction outperforms component approaches. SABER is
the US DCC for this clinical trial and will provide project management, data management,
software development, and statistical analysis.
SUGARNSALT: Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes
and Diabetic Kidney Disease
Principal Investigators: Alessandro Doria, MD, PhD, MPH, Michael Mauer, MD, and David
Cherney, MD, PhD
Sponsor: Juvenile Diabetes Research Foundation (JDRF), Canadian Institute of Health
Research (CIHR), and Kidney Foundation of Canada (KFOC)
The goals of the SUGARNSALT trial are to evaluate the renal effectiveness of Sodium-Glucose
Transport Protein 2 (SGLT2) Inhibitors in Type 1 Diabetes (T1D) and to better understand
the benefit/risk ratio of sotagliflozin (SOTA) in T1D persons with moderate to advanced
diabetic kidney disease (DKD). The study is a multi-center, double-blind, placebo-controlled,
parallel-group randomized clinical trial in 150 patients with T1D and moderate to
advanced DKD. The eGFR at the end of the wash-out adjusted by its baseline value will
be used as the primary outcome on which SOTA efficacy on DKD progression will be evaluated.
SABER is the DCC for this clinical trial and will provide project management, clinical
monitoring, data management, software development, and statistical analysis.
THRIVE: Trajectories of Recovery After Intravenous Propofol vs Inhaled Volatile Anesthesia
Trial
Principal Investigators: Michael Avidan, MBBCH, FCASA and Sachin Kheterpal, MD, MBA
Sponsor: Patient-Centered Outcomes Research Institute (PCORI)
The THRIVE study is a multicenter randomized trial, with randomization to either propofol
TIVA or inhaled volatile general anesthesia (INVA) for patients who are undergoing
elective non-cardiac surgery. Patients will be allocated to one of the two trial arms
using minimization. The primary aims of this trial are to determine whether patients
undergoing (a) major inpatient surgery, (b) minor inpatient surgery, or (c) outpatient
surgery have a superior quality of recovery after INVA or TIVA and whether TIVA confers
no more than a small (0.2%) increased risk of definite intraoperative awareness than
INVA. SABER provides study design and oversight, enrollment reporting, statistical
analysis, data collection infrastructure, informatics pipelines, and participant interaction
for this study.
TOPMed: Trans-Omics for Precision Medicine
Principal Investigator: Goncalo Abecasis, PhD
Sponsor: National Heart, Lung and Blood Institute (NHLBI)
The TOPMed Informatics Research Center (IRC) at the University of Michigan provides
advice to participating studies, sequencing centers and staff at the National Institutes
of Health on the handling, processing and interpretation of large-scale sequence data.
The IRC will jointly analyze sequence data and aid study investigators with informatics
challenges, particularly for cross study analyses. A key goal of the Informatics Research
Center is to make study results easily accessible to a broad range of scientists.
SABER is responsible for assisting the IRC with obtaining and managing any missing
and/or needed data files (i.e. subject consent, subject sample mapping, sample attributes,
pedigree and phenotype) for dbGaP upload and submission for curator review. Additional
support includes preview and approval of dbGaP submissions prior to release to the
public as well as uploading of omics data (RNA sequencing, DNA methylation and metabolomics)
via the dbGaP submission portal.