Northwest Louisiana Nephrology is a full time private practice clinic with 10 full time practicing Physicians of which 9 are Board Certified in Internal Medicine and Nephrology, and 1 Certified Family Nurse Practitioner. The practice has 2 office clinics and 4 satellite clinics in the surrounding ARKLATEX areas. The Physicians oversee and are Medical Directors of 13 Hemodialysis units,1 Peritoneal Dialysis unit and a Transplant Clinic. The practice is affiliated with 7 private hospitals and 4 LTAC facilities in Shreveport, and serves the citizens of the metropolitan area of Shreveport/Bossier and Northwest Louisiana, East Texas, and Southeast Arkansas.
This practice has being participating in research since 2000, founded by the Nephrologists in this practice. The research department consists of 10 nephrologists serving as PI and Sub PI, CFNPs serving as Sub PI, Full time RN, CCRC Research Coordinator /Administrator and full time Staff and Lab assistant.
MISSION STATEMENT: To provide assured quality clinical research services and outcomes, thereby helping to improve the quality of life for patients with Chronic Kidney Disease, transplant, and HD/PD, dialysis.
- Anemia
- Diabetes
- Electrolyte Disorders
- Glomerulonephritis
- HD/PD
- Hypertension
- Kidney biopsies
- Kidney Stone Disease
- Nephrology/ Acute and Chronic Renal Failure
- Osteoporosis
- Proternuria/Hematuria
- Renal Transplantation
- Hyperparathyroidism
- Iron Deficiency
SPONSORS/CROs
- Abbott Laboratories
- Abgenix
- Advance Magnetics
- Affymax
- AMAG
- Amgen
- Averion
- Boehringer Ingelheim
- Care Stat
- Chiltern
- ICON
- Covance
- FibroGen
- GelTex Pharmaceuticals, Inc.
- Kureha
- Luitpold
- Mitsubishi Tanabe Pharma
- nTouch Research
- Ortho Biotech
- Paraxel
- Pharmanet
- PPD
- PRA International
- Quintiles
- Roche
- Spectrum
- Speedel
- Takeda
- Watson
- Research experience since 2000
- 10 full time and 1 Part time practicing Nephrologists and 4 CFNP
- Full-time, Certified clinical research coordinator' RN BSN
- Full-time Certified clinical research Staff - RMA
- Experience in Phase I, II, III, and IV Clinical Trials
- Flexible Central IRB, Local if needed
Philip J. Garavaglia, M.D.
American Board of Internal Medicine, and Nephrology
Sub-specialty
2 years research experience and GCP certified
Robert N. McCoy, M.D.
American Board of Internal Medicine, and Nephrology
Sub-specialty
Research Fellow 1981-1986 2 years research experience
and GCP certified
Raja I. Zabaneh, M.D., F.A.C.P., FASN
American Board of Internal Medicine, and Nephrology Sub-specialty
15 years research experience, GCP certified
Marwan O. Kaskas, M.D., FASN, CCPI
American Board of Internal Medicine and Nephrology Sub-specialty
12 years research experience and GCP certified
Sylvia D. Noble, M.D.
American Board of Internal Medicine and Nephrology
Sub-specialty
2 years research experience with certification -ARCP for P.I. and
GCP
Stephen R. Patton, M.D.
American Board of Internal Medicine and Nephrology
Sub-specialty
2 years research experience and GCP certified
Micheal D. Rokaw, M.D., FASN
American Board of Internal Medicine and Nephrology
Sub-specialty
9 years research experience and GCP certified
Melissa L. Lynn, M.D.
American Board of Internal Medicine and Nephrology
Sub-specialty
2 years research experience and GCP certified
Arnold E. Barz, M.D.
American Board of Internal Medicine and Nephrology
Sub-specialty
1 1/2 years research experience and GCP certified
Nakul Parimoo, M.D.
American Board of Internal Medicine and Nephrology
Sub-specialty.
1 year research experience and GCP certified
Sreedhara B. Alla, M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
Patricia A. Kennedy, CFNP
Louisiana State Board of Nursing eligible and American Nurses
Credentialing Center for Family Nurse Practitioner
GCP certified
D. Blake Smith, CFNP
Louisiana State Board of Nursing eligible and American Nurses
Credentialing Center for Family Nurse practitioner
GCP certified
Audrey Y. Rachal , RN, BSN, MSN, ACNP-BC
Louisiana State Board of Nursing eligible and American
Nurses Credentialing Center for Family Nurse Practitioner
GCP certified
Yeona DaCosta-Auld, RN BSN, CCRC
Research Coordinator-, Administrative
5 years of clinical research
Deanna Ferrell, CCRC
Research Coordinator experience for the past 5 years and ongoing.
RESEARCH STUDIES:
| November 2001- December 2001 | Prevalence of Anemia in Patients With Early Renal
Insufficiency Protocol PR99-06-002 Ortho Biotech, Inc. |
| November 2001' November 2005 | A Randomized, Open Label, Parallel Design Study of Renagel
Phosphate Binder Versus Calcium-Based Phosphate Binders in
Hemodialysis Protocol GTC-68-401 GelTex Pharmaceuticals, Inc. 3 Year Study |
| April 2002– September 2002 | A Phase III Prospective, Randomized Placebo Controlled,
Double-Blind Multi-Center Study to Evaluate the Safety and Efficacy
of Zemplar Capsules in Reducing Serum Intact Parathyroid Hormone
Levels in End Stage renal Disease Subjects on Hemodialysis Protocol HD 2001-014 Abbott Laboratories 28 Week Study |
| May 2002– September 2002 | A Phase III Prospective, Randomized Placebo Controlled,
Double-Blind Multi-Center Study to Evaluate the Safety and Efficacy
of Zemplar Capsules in Reducing Serum Intact Parathyroid Hormone
Levels in End Stage renal Disease Subjects on Peritoneal
Dialysis Protocol 2001-015 Abbott Laboratories 28 Week Study |
| May 2002– June 2003 | A Placebo-controlled, Double–blind, Multicenter Study to Assess
the Efficacy and Safety of an Oral Calcimimetic Agent ( AMG 073) in
Secondary Hyperparathyroidism of Chronic Kidney Disease (
Hemodialysis and Peritoneal Dialysis) Protocol AMG 073 20000188 Amgen 28 Week Study |
| July 2002– January 2006 | Correction of Hemoglobin and Outcomes in Renal Insufficiency
“CHOIR†Protocol PR00-06-014 Ortho Biotech Products, L.P. 3 Year Study |
| July 2002' November 2003 |
“A Randomized Open Label Clinical Evaluation for PROCRIT
(Epoetin Alfa) for Maintenance Phase treatment of Patients with
Anemia due to Chronic Kidney Diseaseâ€. PROMPT Protocol PR01-06-021 Ortho Biotech Products, L.P. 16 Week Study |
| August 2002- October 2004 | A Study of the Efficacy and Safety of Venofer [ Iron Sucrose
Injection] in Anemic Patients Receiving Peritoneal Dialysis Protocol 1VEN02021 Luitpold 71 Day Study |
| March 2003- December2004 | A Randomized, controlled, Open-Label Study of the Safety and
Efficacy of Ferrlecit vs. Oral Iron in Iron Deficient Patients with
Chronic Kidney Disease Being Treated with Erythropoietic
therapy Protocol FER0201 Watson Laboratories, Inc. 10 Week Study |
| March 2003-January 2005 | A Randomized, controlled, Open-Label Study of the Safety and
Efficacy of Ferrlecit vs. Oral Iron in Iron Deficient Patients with
Chronic Kidney Disease Protocol FER0202 Watson Laboratories, Inc. 10 Week Study |
| July 2003- October 2006 | A prospective, randomized, double-blind, double-dummy,
forced-titration, multicentre, parallel group, one year treatment
trial to compare MICARDIS (telmisartan) 80mg versus COZAAR
(losartan) 100mg in hypertensive type 2 diabetic patients with
overt nephropathy (AMADEO Study) Protocol 502.397 Boehringer Ingelheim 58 Weeks Study |
| November 2003—2004 | CONTROL, Cinacalcet, Open Label Study to Reach K/DOQI Level
Phase 2; Protocol # AMG-073 2002 Amgen 52 week study |
| July 2003-December 2004 | A Randomized, Double-blind Study Comparing Aranesp (darbepoetin
alfa) and Recombinant Human Erythropoietin in the treatment of
Anemia in African American Subjects with Chronic Renal Failure
(CRF) Receiving Hemodialysis Protocol Aranesp 20010125 Amgen 33 Weeks Study |
| November 2003' 2004 | TARGET Treatment Strategies to Achieve Recommended K/DOQI Goals
in ESRD Patients on Cinacalet Phase II Protocol #AMG-073 20020390 Amgen 52 week study |
| May 2004- October 2006 | A Phase III, Study of the Safety and Efficacy of Two Parental
Dose, Regimens of Ferumoxytol (compared with oral iron) as an Iron
Replacement Therapy in CKD Patients not on Dialysis Protocol 62745-6 Advance Magnetics Inc. 35 day study |
| August 2004-Current | TREAT- Trial to Reduce Cardiovascular Events with Aranesp
Therapy Protocol 20010184 Amgen 4 year Study |
| November 2004- December 2005 | A Phase III, Multicenter, Randomized, Placebo-Controlled,
Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent
Staphylococcus aureus Glycoconjugate Vaccine in Adults on
Hemodialysis. Protocol NABI-1371 Nabi Biopharmaceuticals 425 day Study |
| August 2004-CurrenMay 2006t | A Prospective Community Cohort Observational Study to Examine
the Prevalence of Abnormalities of Parathyroid Hormone, Calcium,
Phosphorus and Vitamins in Patients with Chronic Kidney
Disease Phase IV Abbott SEEK Abbott Laboratories, Inc. 1 year |
| April 2004-July 2006 | A Phase III An open-label, randomized, multi-center, parallel
group study to demonstrate correction of anemia using subcutaneous
injections of RO0503821 in patients with chronic kidney disease who
are not on renal replacement therapy Protocol BA16738 Hoffmann-LaRoche Ltd. 53 week study. |
| July 2004-October 2005 | Clinical Utility Of Caduet in Simultaneously achieving Blood
Pressure and Lipid endpoints in a Specific Patients Population
(CAPABLE) Protocol A3841025 Pfizer 20 week study |
| April 2005 to Current | A Randomized , Open-Label Study to Asses the Safety of Epoetin
Alfa Manufactured by Deep Tank Technology and Epoetin Alfa
Manufactured by Roller Bottle technology in Subjects with Chronic
Kidney Disease Not on Dialysis Protocol 20040259 Amgen Phase 3' 56 weeks |
| December 2005 to Current | A randomized, Double-Blind, Equivalence Study of the Efficacy
of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and
Epoetin alfa Manufactured by Roller Bottle Technology for the
Treatment of Anemia in patients with Chronic Kidney Disease
Receiving Hemodialysis Amgen Protocol 20050113 Phase 3' 30 week study |
| March 2005 to July 2006 | A three- month, open-label, two cohort study to investigate the
safety and tolerability of Myfortic in combination with Neoral or
Tacrolimus in renal transplant recipients with GI intolerance Novartis MyTime Protocol CERL080 |
| September 2005 to Current |
Avosentan (SPP301) Diabetic Nephropathy A randomized, double blind, placebo controlled, parallel group study to assess the effect of the Endothelin receptor antagonist avosentan on time to doubling of serum Creatinine, end stage renal disease or death in patients with type 2 diabetes mellitus and diabetic nephropathy Speedel ASCEND Protocol SPP301CRD15 Phase 3 4 year study |
| July 2005 to Current | Comparison of the Safety and Efficacy of a Unique Intravenous
Iron Preparation (VIT-45) versus Oral Iron in the Treatment of
Anemia in Non-Dialysis Dependent Chronic Kidney Disease Luitpold Protocol 1VIT04004 IND # 57,103 Phase 3 -56 days Phase 3' 56 days |
| October 2005 to Current | Open Label Extension Evaluating the Long Term Safety,
tolerability and Efficacy of an Iron Maintenance Dosing Strategy
Utilizing Intravenous VIT-45 in the treatment of Anemia in the
Non-Dialysis Dependant (NDD) Chronic Kidney disease (CKD) Luitpold Protocol VIT05005' IND # 63,243 Phase 3' 44 weeks |
| August 2005 to Current | A Phase-IV, Open-Label, Multi-Center Trial Evaluating the
Efficacy of Fosrenol Compared to Exiting Therapy in Adults with End
Stage renal Disease treated for Hyperphosphatemia. Shire Protocol SPD 405-401 Phase 4 -13 weeks |
| March 2005 to Current | An Open-Label, Multi-Center study to Document the Efficacy,
Safety and Tolerability of Long Term Administration of RO0503821 in
Patients with Chronic Kidney Renal Anemia Roche Protocol BH18387 Phase 3' 104 Weeks |
| August 2005 to October 2006 | A Double-Blind, Randomized, Placebo Controlled. Parallel Group,
Multiple Dose Study to assess the Safety, tolerability,
Pharmacokinetics and Pharmacodynamics of ABX10241 in Hemodialysis
Subjects with Secondary Hyperparathyroidism Abgenix Protocol ABX-0504 Phase 1 -26 weeks |
| October 2005 to Current | A Phase 2, Open-Label, Multi-Center, Sequential, Dose Finding
Study if the Safety, Pharmacodynamics, and Pharmacokinetics of
AF37702 Injection (Hematide) Administration Intravenously for the
Maintenance Treatment of Anemia in Chronic Hemodialysis
patients Affymax Protocol AFX01-03 Phase 2 - 15 weeks |
| August 2005- Current | Dialysis patient's Response to IV iron with Elevated
Ferritin DRIVE Watson Protocol FER0401 Phase IV 7-weeks |
| August 2005- 2007 | Dialysis patient's Response to IV iron with Elevated Ferritin DRIVE Protocol FER0401 Watson |
| August 2006 - 2010 | An Open'label, Multi-center, Extension Study to Evaluate the Safety and Tolerability of AF37702 Injection (Hematideâ„¢) for the Long-Term Maintenance treatment of Anemia in Patients With Chronic Kidney Disease Protocol AFX01-09 Affymax |
| September 2006 - 2007 | A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects with Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin FibroGen Protocol FGCL-SM2216-019 |
| August 2006 - 2007 | A Randomized Cross-Over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients Watson Protocol FER0601 |
| August 2006' 2008 | A 4-week, multicenter, double-blind, randomized, parallel group study to compare the gastrointestinal safety and tolerability of myfortic and MMF 9Cellcept) when administered in combination with calcineurin inhibitors in renal transplant recipients experiencing gastrointestinal intolerance Protocol CERL080AUS51 Novartis |
| September 2007' 2010 | A Phase 3, Randomized, Active-Controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Correction of Anemia in the Patients with Chronic Renal Failure (CRF) not on Dialysis and not Erythropoiesis Stimulating Agent (ESA) Treatment Protocol AFX01-11 Affymax |
| September 2007- 2010 | A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated with Epoetin Alfa Protocol: AFX01-12 Affymax |
| July 2007- 2009 | A Phase III, Open-label Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters Protocol N3701g Genentech |
| September 2007' 2008 | A Randomized Controlled Trial of the Effect if IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients Protocol FER0701 Watson |
| October 2007' 2008 | A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability on Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in treating iron Deficiency Anemia in Chronic Kidney Disease patients Protocol 1VIT07018 Luitpold |
| October 2007' 2009 | A Phase 2/3, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects with Lupus Nephritis in Combination with Mycophenolate Mofetil therapy Protocol: ZGI 493G01 MSEO28113 ZymoGentics |
| February 2008' 2009 | Outcome trial Evaluating the Efficacy and Safety of Norditropin in Adult Patients on Chronic Hemodialysis. A Randomized , Double-blind, Parallel group, Placebo controlled, Multi-centre Trial. Protocol: NN1630-1453- OPPORTUNITY Novo Nordisk |
| February 2008 - 2009 | A Multi-center, Randomized Double-Blind, Active controlled Clinical trial to Evaluate the Safety and Tolerability of 24 weeks treatment with Vildagliptin (50mg qd) versus Sitagliptin (25mg qd) in patients with type 2 diabetes and severe renal insufficiency Protocol: CLAF237A23138 Novartis |
| March 2008' 2009 | A Randomized, Open-label, Multicenter, Study of Epoetin Alfa Comparing Two Extended Dosing regimens, Once Every Two Weeks and Once Every Four Weeks, with the Once Weekly dosing Regimen for Maintenance Treatment in Anemia Subjects With Chronic Kidney Disease Protocol EPO-AKD-3002 Johnson & Johnson Pharmaceuticals |
| August 2008- Current | A 30-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects with Stage 3 Chronic Kidney Disease Protocol M10-313 Abbott |
| July 2008 - April 2010 | A Phase 2 Study and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Subjects with Chronic Renal Failure who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepotein Alfa Protocol AFX01_202 Takeda |
| January 2009 - 2010 | A Phase 2 Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Subjects Previously Treated With Epotein Protocol AFX01_201 Takeda |
| April 2009' Current | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease Protocol KRM-306 EPPIC Mitsubishi Tanabe - Kureha |
| January 2009' 2010 | “A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biological Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects with Chronic Kidney Disease†Protocol FGCL-SM4592-017 FibroGen |
| December 2009' Current | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics and Safety of Escalating Dose Levels of FG-4592 in Subjects with End-Stage Renal Disease Receiving Maintenance Hemodialysis Protocol FGCL-4592-039 FibroGen |
| December 2009' Current | Randomized Evaluation of efficacy and safety of Ferric Carboxymaltose in Patients with iron deficiency Anemia and Impaired Renal function. REPAIR-IDA Protocol 1VIT09030 Luitpold |
| April 2010' Current | Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, trail of Ferumoxytol Compared to Iron Sucrose for the Treatment of IRON Deficiency Anemia in Adult Subjects with Chronic Kidney Disease Protocol FER-CKD-201 AMAG |
10,000 clinic patients
250 renal transplant patients
700 hemodialysis patients
40 peritoneal dialysis patients
The practice does see 1000 new patients per year either as outpatient or inpatient referrals.
Endocrinology
Hematology
Musculoskeletal
Nephrology/Urology
Rheumatology
Northwest Louisiana Nephrology has been in private practice for the past 25 years. The practice has expanded over the years to include 10 nephrologists, of which 9 are board certified, 2 CFNP, 1 RN (CCRC), (current member with ARCP), 1 LPN and 1 Lab assistant. 2 office clinics, a Transplant clinic and 5 satellite clinics. The Physicians are affiliated with 7 hospitals and 5 LTACs hospital serving the population with both outpatient/inpatient services. Research is conducted at the Buckner Clinic, and HD/PD centers.
Our facility is 20 minutes form the Shreveport Regional Airport. We are within 5-30 minutes from 7 HD/PD centers and hospitals and 30-90 minutes from 6 HD centers. The Research office is within 10-15 minutes from major hotels and we have the major rent-a car company or the use of cabs.
Our practice has dedicated area for research and is equipped with a phone line for computer and personal phones. Additionally, we have an EKG machine, vital checks, Lab with refrigerated centrifuge, refrigerator for medication and -20 degrees freezer, and dry ice capabilities.
Yeona DaCosta-Auld
Research Coordinator
Northwest Louisiana Nephrology
1800 Buckner Street, Suite C-120
Shreveport, LA 71101
USA
318-220-9792
318-220-9794 (fax)
yauld@nwln.com