ID

14912

Description

The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE; ODM derived from: https://clinicaltrials.gov/show/NCT02258074

Link

https://clinicaltrials.gov/show/NCT02258074

Keywords

Versions (1)
  1. 5/7/16 5/7/16 -
Uploaded on

May 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT02258074

English

Eligibility Chronic Kidney Disease NCT02258074

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with estimated glomerular filtration rate (egfr) 20-45 ml/min/1.73m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
2. age 18-85 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. serum phosphate ≥ 2.8 mg/dl
Description

Serum Phosphate Measurement

Data type

boolean

Alias
UMLS CUI [1]
C1883013
4. platelet count ≥ 125,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
5. able to provide consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. able to travel to study visits
Description

Ability travel Clinical Research Patient Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0040802
UMLS CUI [1,3]
C0008972
UMLS CUI [1,4]
C1512346
7. able to eat at least two meals a day
Description

Able to eat Two Meal per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0566305
UMLS CUI [1,2]
C0205448
UMLS CUI [1,3]
C1998602
UMLS CUI [1,4]
C0439505
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.
Description

Study Protocol Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of allergic reaction to nicotinamide, niacin (excluding flushing), multivitamin preparations, or lanthanum carbonate
Description

Allergic Reaction Niacinamide | Allergic Reaction Niacin | Allergic Reaction Multivitamin preparation | Allergic Reaction lanthanum carbonate

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0028027
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0027996
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0301532
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0768119
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
Description

Liver Cirrhosis | Alcohol consumption | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline Phosphatase | Bilirubin, total measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0001948
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0002059
UMLS CUI [6]
C0201913
3. creatine kinase (ck) concentrations > 2 times the upper limit of the local laboratory reference range
Description

Creatine Kinase

Data type

boolean

Alias
UMLS CUI [1]
C0010287
4. major hemorrhagic event within the past six months requiring in-patient admission
Description

Hemorrhage Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019993
5. blood or platelet transfusion within the past six months
Description

Blood Transfusion | Platelet Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0005841
UMLS CUI [2]
C0086818
6. secondary hyperparathyroidism (pth > 5 times the upper limit of normal range for the laboratory) or currently taking cinacalcet (sensipar)
Description

Hyperparathyroidism, Secondary | Intake cinacalcet Sensipar

Data type

boolean

Alias
UMLS CUI [1]
C0020503
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C1337242
UMLS CUI [2,3]
C1435704
7. current, clinically significant malabsorption, as determined at the discretion of the site investigator
Description

Malabsorption Syndrome Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C2826293
8. anemia (screening hg < 9.0 g/dl)
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
9. serum albumin < 2.5 mg/dl
Description

Serum Albumin

Data type

boolean

Alias
UMLS CUI [1]
C0036773
10. anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by and at the discretion of the site investigator.
Description

Initiation Dialysis procedure | Initiation Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C0011946
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0022671
11. use of immunosuppressive medications (stable oral steroids ≤ 10 mg of prednisone/day or inhaled steroids are exempted)
Description

Immunosuppressive Agents | Adrenal Cortex Hormones Stable status | Prednisone | inhaled steroids

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0032952
UMLS CUI [4]
C2065041
12. in the opinion of the site investigator, active abuse of alcohol or drugs
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
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.
Description

Therapeutic procedure Calcitriol | Vitamin D Analog | paricalcitol | Hectorol

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0006674
UMLS CUI [2]
C2917444
UMLS CUI [3]
C0249582
UMLS CUI [4]
C0876052
14. current or recent treatment (within the last 14 days) with phosphate binder or niacin/nicotinamide > 100 mg/day
Description

Therapeutic procedure Phosphate Binder | Therapeutic procedure Niacin | Therapeutic procedure Niacinamide

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2267031
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0027996
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0028027
15. current participation in another clinical trial or other interventional research
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
16. currently taking investigational drugs
Description

Intake Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0013230
17. institutionalized individuals, including prisoners and nursing home residents
Description

Prisoners | Nursing home resident

Data type

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2]
C0682287
18. malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)
Description

Malignant Neoplasms Requirement Therapeutic procedure | Basal cell carcinoma | Squamous cell carcinoma of skin | Prostate carcinoma Localized

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4,1]
C0600139
UMLS CUI [4,2]
C0392752
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Similar models

Eligibility Chronic Kidney Disease NCT02258074

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
1. patients with estimated glomerular filtration rate (egfr) 20-45 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Age
Item
2. age 18-85 years
boolean
C0001779 (UMLS CUI [1])
Serum Phosphate Measurement
Item
3. serum phosphate ≥ 2.8 mg/dl
boolean
C1883013 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelet count ≥ 125,000/mm3
boolean
C0032181 (UMLS CUI [1])
Informed Consent
Item
5. able to provide consent
boolean
C0021430 (UMLS CUI [1])
Ability travel Clinical Research Patient Visit
Item
6. able to travel to study visits
boolean
C0085732 (UMLS CUI [1,1])
C0040802 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C1512346 (UMLS CUI [1,4])
Able to eat Two Meal per day
Item
7. able to eat at least two meals a day
boolean
C0566305 (UMLS CUI [1,1])
C0205448 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
Study Protocol Compliance behavior
Item
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.
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Niacinamide | Allergic Reaction Niacin | Allergic Reaction Multivitamin preparation | Allergic Reaction lanthanum carbonate
Item
1. history of allergic reaction to nicotinamide, niacin (excluding flushing), multivitamin preparations, or lanthanum carbonate
boolean
C1527304 (UMLS CUI [1,1])
C0028027 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0027996 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0301532 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0768119 (UMLS CUI [4,2])
Liver Cirrhosis | Alcohol consumption | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline Phosphatase | Bilirubin, total measurement
Item
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
boolean
C0023890 (UMLS CUI [1])
C0001948 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0002059 (UMLS CUI [5])
C0201913 (UMLS CUI [6])
Creatine Kinase
Item
3. creatine kinase (ck) concentrations > 2 times the upper limit of the local laboratory reference range
boolean
C0010287 (UMLS CUI [1])
Hemorrhage Hospitalization
Item
4. major hemorrhagic event within the past six months requiring in-patient admission
boolean
C0019080 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Blood Transfusion | Platelet Transfusion
Item
5. blood or platelet transfusion within the past six months
boolean
C0005841 (UMLS CUI [1])
C0086818 (UMLS CUI [2])
Hyperparathyroidism, Secondary | Intake cinacalcet Sensipar
Item
6. secondary hyperparathyroidism (pth > 5 times the upper limit of normal range for the laboratory) or currently taking cinacalcet (sensipar)
boolean
C0020503 (UMLS CUI [1])
C1512806 (UMLS CUI [2,1])
C1337242 (UMLS CUI [2,2])
C1435704 (UMLS CUI [2,3])
Malabsorption Syndrome Clinical Significance
Item
7. current, clinically significant malabsorption, as determined at the discretion of the site investigator
boolean
C0024523 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Anemia
Item
8. anemia (screening hg < 9.0 g/dl)
boolean
C0002871 (UMLS CUI [1])
Serum Albumin
Item
9. serum albumin < 2.5 mg/dl
boolean
C0036773 (UMLS CUI [1])
Initiation Dialysis procedure | Initiation Kidney Transplantation
Item
10. anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by and at the discretion of the site investigator.
boolean
C1704686 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C1704686 (UMLS CUI [2,1])
C0022671 (UMLS CUI [2,2])
Immunosuppressive Agents | Adrenal Cortex Hormones Stable status | Prednisone | inhaled steroids
Item
11. use of immunosuppressive medications (stable oral steroids ≤ 10 mg of prednisone/day or inhaled steroids are exempted)
boolean
C0021081 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0032952 (UMLS CUI [3])
C2065041 (UMLS CUI [4])
Substance Use Disorders
Item
12. in the opinion of the site investigator, active abuse of alcohol or drugs
boolean
C0038586 (UMLS CUI [1])
Therapeutic procedure Calcitriol | Vitamin D Analog | paricalcitol | Hectorol
Item
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.
boolean
C0087111 (UMLS CUI [1,1])
C0006674 (UMLS CUI [1,2])
C2917444 (UMLS CUI [2])
C0249582 (UMLS CUI [3])
C0876052 (UMLS CUI [4])
Therapeutic procedure Phosphate Binder | Therapeutic procedure Niacin | Therapeutic procedure Niacinamide
Item
14. current or recent treatment (within the last 14 days) with phosphate binder or niacin/nicotinamide > 100 mg/day
boolean
C0087111 (UMLS CUI [1,1])
C2267031 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0027996 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0028027 (UMLS CUI [3,2])
Study Subject Participation Status
Item
15. current participation in another clinical trial or other interventional research
boolean
C2348568 (UMLS CUI [1])
Intake Investigational New Drugs
Item
16. currently taking investigational drugs
boolean
C1512806 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Prisoners | Nursing home resident
Item
17. institutionalized individuals, including prisoners and nursing home residents
boolean
C0033167 (UMLS CUI [1])
C0682287 (UMLS CUI [2])
Malignant Neoplasms Requirement Therapeutic procedure | Basal cell carcinoma | Squamous cell carcinoma of skin | Prostate carcinoma Localized
Item
18. malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0600139 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
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