Phase 2
Completed N=205
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
Source: ClinicalTrials.gov NCT02258074 ↗Enrolled (actual)
205
Serious AEs
29.3%
Results posted
Jul 2021
Primary outcomePrimary: FGF23 — .047; -.003; .193; .138 pg/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FGF23 |
.047; -.003; .193; .138 | — |
| PRIMARY Serum Phosphate (mg/dl) |
0.06; 0.06; 0.12; 0.12 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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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Data sourced from ClinicalTrials.gov (NCT02258074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.