The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: Nicotinamide (Drug); Lanthanum Carbonate (Drug); Placebo (for Nicotinamide) (Drug); Placebo (for lanthanum carbonate) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: John Kusek Official(s) and/or principal investigator(s): Michael F. Flessner, MD, PhD, Study Director, Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) John W. Kusek, PhD, Study Director, Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Jennifer J Gassman, Ph.D., Principal Investigator, Affiliation: Data Coordinating Center, Cleveland Clinic Linda F Fried, MD, Study Chair, Affiliation: University of Pittsburgh
Summary
The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and
lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients
with Chronic Kidney Disease (CKD) stages 3-4.
Clinical Details
Official title: The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Primary outcome: Since this is a Pilot Study, the primary outcome measures is feasibility. The clinical outcome measure is change from baseline to 12 months in serum phosphate and FGF23 levels
Secondary outcome: Change from baseline in bone and mineral metabolism markersChange from baseline in surrogate measures of cardiovascular disease (CVD) risk over 12 months Change from baseline in surrogate measures of CKD progression and inflammation, by changes in intra-renal oxygenation and fibrosis over 12 months
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with estimated glomerular filtration rate (eGFR) 20-45 ml/min/1. 73m2
2. Age 18-85 years
3. Serum phosphate ≥ 2. 8 mg/dL
4. Platelet count ≥ 125,000/mm3
5. Able to provide consent
6. Able to travel to study visits
7. Able to eat at least two meals a day
8. In the opinion of the site investigator, willing and able to follow the study
treatment regimen and comply with the site investigator's recommendations.
Exclusion Criteria:
1. History of allergic reaction to nicotinamide, niacin (excluding flushing),
multivitamin preparations, or lanthanum carbonate
2. Liver disease, defined as known cirrhosis by imaging or physician diagnosis,
documented alcohol use > 14 drinks/week, or aspartate aminotransferase (AST), alanine
aminotransferase (ALT), alkaline phosphatase, or total bilirubin concentrations > 2
times the upper limit of the local laboratory reference range
3. Creatine kinase (CK) concentrations > 2 times the upper limit of the local laboratory
reference range
4. Major hemorrhagic event within the past six months requiring in-patient admission
5. Blood or platelet transfusion within the past six months
6. Secondary hyperparathyroidism (PTH > 5 times the upper limit of normal range for the
laboratory) or currently taking cinacalcet (Sensipar)
7. Current, clinically significant malabsorption, as determined at the discretion of the
site investigator
8. Anemia (screening Hg < 9. 0 g/dl)
9. Serum albumin < 2. 5 mg/dl
10. Anticipated initiation of dialysis or kidney transplantation within 12 months as
assessed by and at the discretion of the site investigator.
11. Use of immunosuppressive medications (stable oral steroids ≤ 10 mg of prednisone/day
or inhaled steroids are exempted)
12. In the opinion of the site investigator, active abuse of alcohol or drugs
13. Recent (within the last 14 days) initiation or change in dose of treatment with 1,25
(OH)2 vitamin D or active vitamin D analogues (paricalcitol or hectorol). Patients
on stable doses of these agents initiated more than 14 days prior to screening are
eligible to participate.
14. Current or recent treatment (within the last 14 days) with phosphate binder or
niacin/nicotinamide > 100 mg/day
15. Current participation in another clinical trial or other interventional research
16. Currently taking investigational drugs
17. Institutionalized individuals, including prisoners and nursing home residents
18. Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma
and localized prostate cancer are exempted)
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Locations and Contacts
University of California at San Diego, San Diego, California 92161, United States; Recruiting Joachim Ix, M.D., Phone: 858-552-8585, Ext: 1657 Joachim Ix, MD, Principal Investigator
Denver Nephrology Research, Denver, Colorado 80230, United States; Recruiting Martha Persky, RN, Phone: 303-364-4775, Email: mpersky@dnresearch.org Geoffrey Block, MD, Principal Investigator
George Washington University, Washington, District of Columbia 20037, United States; Recruiting Maria Wing, Ph.D., Phone: 202-741-2220, Email: mwing@mfa.gwu.edu Dominic Raj, MD, Principal Investigator
NorthShore University Health System, Chicago, Illinois 60201, United States; Recruiting Fettman Shonny, RN, MS, CCRP, Phone: 847-570-1761, Email: sfettman@northshore.org Stuart Sprague, DO, Principal Investigator
Northwestern University, Chicago, Illinois 60611, United States; Recruiting Michelle Bradley, MPH, CCRP, Phone: 312-503-1909, Email: michelle.bradley@northwestern.edu Myles Wolf, MD, Principal Investigator Tamara Isakova, MD, Sub-Investigator
University of Utah, Salt Lake City, Utah 84112, United States; Recruiting Jennifer Zitterkoph, Phone: 801-585-1897, Email: Jennifer.zitterkoph@hsc.utah.edu Alfred Cheung, MD, Principal Investigator Kalani Raphael, MD, Principal Investigator
Utah VA, Salt Lake City, Utah 84112, United States; Recruiting Katt Mackin, Phone: 801-582-1565, Ext: 1798, Email: Katherine.mackin@hsc.utah.edu Kalani Raphael, MD, Principal Investigator Alfred Cheung, MD, Principal Investigator
Additional Information
Starting date: March 2015
Last updated: March 30, 2015
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