N/A
N=100
Oral Paricalcitol in Kidney Transplant Recipients
Transplant; Failure, Kidney · Renal Disease, End Stage · Hyperparathyroidism, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT00587158 ↗Enrolled (actual)
100
Serious AEs
43.0%
Results posted
May 2013
Primary outcome: Primary: Number of Subjects With Hyperparathyroidism at One Year — 31; 15 Participants — p=0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Paricalcitol (Drug); Corticosteroid Avoidance Immune Suppression Protocol (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Hyperparathyroidism at One Year |
31; 15 | 0.0005 sig |
| SECONDARY Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year |
9; 12 | 0.4571 |
| SECONDARY Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year |
9; 14 | 0.2290 |
| SECONDARY Serum Parathyroid Hormone (PTH) Level Over Time |
236; 198; 69; 50; 70; 42 | 0.17 |
| SECONDARY Serum Bone Alkaline Phosphatase (BAP) Level Over Time |
14; 13; 16.5; 17; 21; 12 | 0.833 |
| SECONDARY Change in Lumbar Spine Bone Mineral Density (BMD) |
0.35; 0.35 | 0.98 |
| SECONDARY Change in Hip Bone Mineral Density (BMD) |
0.15; 0.21 | 0.41 |
| SECONDARY Number of Subjects Who Died or Lost Their Renal Graft During First Year |
0; 1 | — |
| SECONDARY Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant |
5; 4 | — |
| SECONDARY Mean Estimated Glomerular Filtration Rate (eGFR) at One Year |
52.7; 51.2 | 0.66 |
| SECONDARY Mean Change in Estimated Glomerular Filtration Rate (eGFR) Between 3 Weeks and 1 Year Post Transplant |
7.4; 6.2 | 0.66 |
| SECONDARY 24-hour Total Protein in the Urine at 1 Year Post Transplant |
420.8; 159.4 | 0.11 |
| SECONDARY Degree of Interstitial Fibrosis on Graft Biopsy at One Year |
19; 19; 4; 0 | 1.0 |
Summary
This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name Zemplar®) as compared to kidney transplant recipients not taking this medication. The main possible benefits being studied are:
* Lower risk for overactive parathyroid glands after kidney transplantation.
* Lower risk of low bone density in the spine and hip after kidney transplantation. By dividing patients in the study into a group receiving Zemplar® and a group not receiving Zemplar®, it will be possible to understand the good and bad effects of Zemplar® during the first year after a kidney transplant.
Eligibility Criteria
Inclusion Criteria
- Age 18 years and older.
- First or second deceased donor or living donor renal transplant.
- Normocalcemia or hypocalcemia.
- Willing to give informed consent
Exclusion Criteria
- Third or subsequent renal transplant.
- Incompatible blood type or positive cross-match donor.
- Multiple organ transplant recipients.
- Diabetic with plans for future pancreas or islet transplant.
- Evidence of donor-specific sensitization (positive T-cell and/or B-cell flow cytometric cross-match).
- Documented hypercalcemia (total serum calcium 10.5 mg/dl on two separate occasions) prior to transplantation.
- Serum 25(OH)vitamin D concentration ≤ 10 ng/ml
Data sourced from ClinicalTrials.gov (NCT00587158). 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.