Establishing a Database on the Plasma Level of Klotho in Humans, in Health and Disease

Study ID
STU 022011-126

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Ashlei Johnson-Wilder
214-648-0394
ashlei.johnson@utsouthwestern.edu

Principal Investigator
Orson Moe

Summary

Subjects
inclusion:
aim 1: one hundred eighty adult subjects, age 18 or older will be equally distributed in the following age groups (years): 21-30, 31-40, 41-50, 51-60, 61-70 and [Greater Than]71. in each age group there will be 8 female and 8 male subjects. We also wish to collect serum ceruloplasmin in a subset (20 subjects) in healthy volunteers to use as a control for the serum ceruloplasmin collected in the dialysis patients from aim 2. The additional enrollment (64)is to compensate for those subjects that have not completed the entire study.
aim 2: Two hundred adult patients 18 years of age with a history of renal disease, 100 female and 100 male, will be selected through consecutive sampling from the uTSW Renal Clinic, the university Hospitals and from the Renal Clinic, the Dialysis unit, and from inpatient renal patients at Parkland Hospital. These patients will be equally distributed according to their eGFR among the five groups of eGFR. The eGFR groups are defined as: group1: eGFR [Greater Than]91 ml/min; groups 2: eGFR 60-89 ml/min; eGFR 3: 30-59 ml/min; eGFR 4: 15-29 ml/min; eGFR 5: [Less Than]15 ml/min. eGFR will be calculated using the following formula: eGFR [?] 170 x [PCr]-0.999 x [age]-0.176 x [0.762 if pt. is female] x [1.180 if pt. is black] x [Sun]-0.170 x [alb]+0.318 as described previously [23].
aim 3: Fifty adult subjects greater than 18 years with a history of calcium kidney stones from the Mineral Metabolism Clinic at aston. The patients will be equally distributed in the following age groups: 18-30, 31-40, 41-50, 5 1-60, 61-70 and [Greater Than]71. Fifty adult subjects greater than 18 years with a history of uric acid kidney stones from the Mineral Metabolism Clinic at aston. The patients will be equally distributed in the following age groups: 18-30, 31-40, 41-50, 5 1-60, 61-70 and [Greater Than]71.
aim 4: 100 aKi patients and 100 high risk patients, as well as fifty healthy aged and gender-matched control subjects. Healthy volunteers have been recruited from uTSW staff and students which are already in our database. We only have to recruit 50 aKi patients for aim 4. Subjects will be between the ages of 18 and 75 years of age, of either gender and any race or ethnicity. any patient who fits definition of aKi as any of the following: increase in PCr by [GreaterThanorequalTo]0.3 mg/dl within 48 hours; or an increase in PCr to [GreaterThanorequalTo]1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume [Less Than]0.5 ml/kg/h for 6 hours following KDiGo Clinical Practice Guideline for acute Kidney injury 2012 (regardless of etiology) (www.kdigo.org).

Participant Eligibility

Aim 1: One hundred eighty adult subjects, age 18 or older will be equally distributed in the following age groups (years): 21-30, 31-40, 41-50, 51-60, 61-70 and >71. In each age group there will be 8 female and 8 male subjects. We also wish to collect serum ceruloplasmin in a subset (20 subjects) in healthy volunteers to use as a control for the serum ceruloplasmin collected in the dialysis patients from Aim 2. The additional enrollment (64)is to compensate for those subjects that have not completed the entire study.
Aim 2: Two hundred adult patients 18 years of age with a history of renal disease, 100 female and 100 male, will be selected through consecutive sampling from the UTSW Renal Clinic, the University Hospitals and from the Renal Clinic, the Dialysis Unit, and from inpatient renal patients at Parkland Hospital. These patients will be equally distributed according to their eGFR among the five groups of eGFR. The eGFR groups are defined as: group1: eGFR >91 ml/min; groups 2: eGFR 60-89 ml/min; eGFR 3: 30-59 ml/min; eGFR 4: 15-29 ml/min; eGFR 5: <15 ml/min. eGFR will be calculated using the following formula: eGFR = 170 x [PCr]-0.999 x [Age]-0.176 x [0.762 if pt. is female] x [1.180 if pt. is black] x [SUN]-0.170 x [Alb]+0.318 as described previously [23].
Aim 3: Fifty adult subjects greater than 18 years with a history of calcium kidney stones from the Mineral Metabolism Clinic at Aston. The patients will be equally distributed in the following age groups: 18-30, 31-40, 41-50, 5 1-60, 61-70 and >71. Fifty adult subjects greater than 18 years with a history of uric acid kidney stones from the Mineral Metabolism Clinic at Aston. The patients will be equally distributed in the following age groups: 18-30, 31-40, 41-50, 5 1-60, 61-70 and >71.
Aim 4: 100 AKI patients and 100 high risk patients, as well as fifty healthy aged and gender-matched control subjects. Healthy volunteers have been recruited from UTSW staff and students which are already in our database. We only have to recruit 50 AKI patients for Aim 4. Subjects will be between the ages of 18 and 75 years of age, of either gender and any race or ethnicity. Any patient who fits definition of AKI as any of the following: Increase in PCr by >=0.3 mg/dl within 48 hours; or an increase in PCr to >=1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume <0.5 ml/kg/h for 6 hours following KDIGO Clinical Practice Guideline for Acute Kidney Injury 2012 (regardless of etiology) (www.kdigo.org).