Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Vitamin D
Brief summary
The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.
Interventions
DRUGParicalcitol
2 mcg oral Paricalcitol once per day for 7 days
Sponsors
Abbott
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Stage 3 or 4 CKD * Ability to give informed consent
Exclusion criteria
* Serum Calcium \> 10 g/dL * Serum Phosphorous \> 6 g/dL * On \> 400 units/d Vitamin D therapy * Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine secretion * On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar) * Allergic to radiocontrast dye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Urine Creatinine Excretion Rate | 1 Week | We expect the 24 hour urine creatinine excretion rate to show no differences between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine Clearance | 1 Week | The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods. |
| Serum Creatinine | 1 Week | We expect serum creatinine to confirm the results of creatinine clearance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Paricalcitol |
|---|---|
| Age Continuous | 69.6 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
24-hour Urine Creatinine Excretion Rate
We expect the 24 hour urine creatinine excretion rate to show no differences between groups.
Time frame: 1 Week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Paricalcitol | 24-hour Urine Creatinine Excretion Rate | 17.6 mg/24hour/day |
Secondary
Creatinine Clearance
The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.
Time frame: 1 Week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Paricalcitol | Creatinine Clearance | 0.49 ml/min |
Secondary
Serum Creatinine
We expect serum creatinine to confirm the results of creatinine clearance.
Time frame: 1 Week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Paricalcitol | Serum Creatinine | 0.010 mg/dl/day |