Summary

for people ages 18-85 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Keywords

Chronic Kidney Disease Kidney Diseases Renal Insufficiency, Chronic Niacinamide Niacin Nicotinic Acids Nicotinamide Lanthanum Carbonate Lanthanum carbonate + nicotinamide

Eligibility

You can join if…

Open to people ages 18-85

  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.

You CAN'T join if...

  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)

Locations

  • University of California at San Diego
    San Diego California 92161 United States
  • University of Utah
    Salt Lake City Utah 84112 United States
  • Utah VA
    Salt Lake City Utah 84112 United States
  • Denver Nephrology Research
    Denver Colorado 80230 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jennifer Gassman
ID
NCT02258074
Phase
Phase 3
Study Type
Interventional
Last Updated
October 31, 2017