Status:
COMPLETED
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 Di...
Eligibility Criteria
Inclusion
- Patients with estimated glomerular filtration rate (eGFR) 20-45 ml/min/1.73m2
- Age 18-85 years
- Serum phosphate ≥ 2.8 mg/dL
- Platelet count ≥ 125,000/mm3
- Able to provide consent
- Able to travel to study visits
- Able to eat at least two meals a day
- 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
- History of allergic reaction to nicotinamide, niacin (excluding flushing), multivitamin preparations, or lanthanum carbonate
- 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
- Creatine kinase (CK) concentrations \> 2 times the upper limit of the local laboratory reference range
- Major hemorrhagic event within the past six months requiring in-patient admission
- Blood or platelet transfusion within the past six months
- Secondary hyperparathyroidism (PTH \> 5 times the upper limit of normal range for the laboratory) or currently taking cinacalcet (Sensipar)
- Current, clinically significant malabsorption, as determined at the discretion of the site investigator
- Anemia (screening Hg \< 9.0 g/dl)
- Serum albumin \< 2.5 mg/dl
- Anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by and at the discretion of the site investigator.
- Use of immunosuppressive medications (stable oral steroids ≤ 10 mg of prednisone/day or inhaled steroids are exempted)
- In the opinion of the site investigator, active abuse of alcohol or drugs
- 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.
- Current or recent treatment (within the last 14 days) with phosphate binder or niacin/nicotinamide \> 100 mg/day
- Current participation in another clinical trial or other interventional research
- Currently taking investigational drugs
- Institutionalized individuals, including prisoners and nursing home residents
- Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)
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Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT02258074
Start Date
March 1 2015
End Date
September 1 2019
Last Update
August 2 2021
Active Locations (7)
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1
University of California at San Diego
San Diego, California, United States, 92161
2
Denver Nephrology Research
Denver, Colorado, United States, 80230
3
George Washington University
Washington D.C., District of Columbia, United States, 20037
4
NorthShore University Health System
Chicago, Illinois, United States, 60201