Trial · NCT00587158
Oral Paricalcitol in Kidney Transplant Recipients
NCT00587158, Not applicable, Completed, Mayo Clinic; results first posted 2013-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Paricalcitol in Kidney Transplant Recipients. Trials, record NCT00587158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00587158
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Paricalcitol in Kidney Transplant Recipients
- NCT number
- NCT00587158
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 100 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Transplant; Failure, Kidney, Renal Disease, End Stage, Hyperparathyroidism, Secondary
- Interventions
- Paricalcitol, Corticosteroid Avoidance Immune Suppression Protocol
- First posted
- 2008-01-07
- Last updated
- 2013-05-13
- Results first posted
- 2013-05-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Hyperparathyroidism at One Year | 1 year post kidney transplant | Parathyroid hormone (PTH) is a measure of how well the parathyroid gland is working and is measured by a blood test. Hyperparathyroidism (increased PTH) is defined as PTH blood value greater than 65 picograms/milliliter in the absence of hypocalcemia (low calcium) or if the subject had a parathyroidectomy (surgical removal of parathyroid glands) during the first year post-transplant. |
| Secondary | Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year | 1 year post kidney transplant | Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the hip made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the hip at the end of the first post-transplant year based on bone mineral density results. |
| Secondary | Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year | 1 year post kidney transplant | Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the lower spine made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the lumbar spine at the end of the first post-transplant year based on bone mineral density results. |
| Secondary | Serum Parathyroid Hormone (PTH) Level Over Time | Baseline, 3 weeks, 3 months, 1 year post kidney transplant | Parathyroid hormone (PTH) is a hormone synthesized in the body's parathyroid glands that controls bone health. PTH controls calcium and phosphorus levels in the body. It is measured in the serum and reported in picograms per milliliter (pg/mL). |
| Secondary | Serum Bone Alkaline Phosphatase (BAP) Level Over Time | Baseline, 21 days, 90 days and 1 year post kidney transplant | BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L). |
| Secondary | Change in Lumbar Spine Bone Mineral Density (BMD) | Baseline, 1 year post kidney transplant | BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements of the lower spine made using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported. |
| Secondary | Change in Hip Bone Mineral Density (BMD) | Baseline, 1 year post kidney transplant | BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements made of the hip bones using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported. |
| Secondary | Number of Subjects Who Died or Lost Their Renal Graft During First Year | Baseline to 1 year post kidney transplant | The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here. |
| Secondary | Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant | Baseline to 1 year post kidney transplant | The number of episodes of ACR, as proven by renal biopsy, were recorded. |
| Secondary | Mean Estimated Glomerular Filtration Rate (eGFR) at One Year | 1 year post kidney transplant | Glomerular filtration rate describes the amount that fluid is filtered through the kidney and can be estimated by using serum creatinine. eGFR is reported in milliliters per minute per 1.73 m\^2 of body-surface area. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Hyperparathyroidism at One Year | 1 year post kidney transplant | Analysis was performed by the intention-to-treat principle, comprised of all subjects enrolled, who will have taken at least one dose of study medication and have both screening and any post-screening efficacy data recorded. The last observation was carried forward for missing values. | Participants | NUMBER |
| SECONDARY | Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year | 1 year post kidney transplant | Per-protocol analysis. Data were not available for 2 control subjects and 2 treatment subjects, as these subjects did not have the DEXA scan of the hip done at one year. \[Control n=42/ Treatment=41\] | Participants | NUMBER |
| SECONDARY | Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year | 1 year post kidney transplant | Per-protocol analysis; Data were not available for 1 subject from each arm because these subjects did not have the one year DEXA scan of the spine. \[Control n = 43/Treatment n = 42\]. | Participants | NUMBER |
| SECONDARY | Serum Parathyroid Hormone (PTH) Level Over Time | Baseline, 3 weeks, 3 months, 1 year post kidney transplant | Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified timepoints. The number of subjects samples per treatment group were as follows \[Timepoint: Control(n)/Treatment(n)\]:~Baseline: 43/41, Day 21: 44/41, Day 90: 44/43, Day 365: 44/43 | pg/mL | MEDIAN |
| SECONDARY | Serum Bone Alkaline Phosphatase (BAP) Level Over Time | Baseline, 21 days, 90 days and 1 year post kidney transplant | Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified study visits. The number of subjects samples per treatment group were as follows \[Timepoint: Control(n)/Treatment(n)\]:~Baseline: 43/41, Day 21: 34/38, Day 90: 36/36, Day 365: 43/41 | mcg/L | MEDIAN |
| SECONDARY | Change in Lumbar Spine Bone Mineral Density (BMD) | Baseline, 1 year post kidney transplant | Per-protocol analysis; Not all subjects were able to undergo the DEXA scan of the spine at baseline and one-year \[Control n = 42/Treatment n = 41\]. | T-score | MEAN |
| SECONDARY | Change in Hip Bone Mineral Density (BMD) | Baseline, 1 year post kidney transplant | Per-protocol analysis. Not all subjects were able to undergo the DEXA scan of the hip at baseline and one-year \[Control n = 41/Treatment n = 40\]. | T-score | MEAN |
| SECONDARY | Number of Subjects Who Died or Lost Their Renal Graft During First Year | Baseline to 1 year post kidney transplant | Per-protocol analysis. | participants | NUMBER |
| SECONDARY | Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant | Baseline to 1 year post kidney transplant | Per-protocol analysis. | episodes | NUMBER |
| SECONDARY | Mean Estimated Glomerular Filtration Rate (eGFR) at One Year | 1 year post kidney transplant | Per-protocol analysis | mL/min/1.73m^2 | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Hyperparathyroidism at One Year | Immunosuppression Without Paricalcitol (Control) | 31 | Participants | ||
| Number of Subjects With Hyperparathyroidism at One Year | Immunosuppression With Paricalcitol | 15 | Participants | ||
| Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year | Immunosuppression Without Paricalcitol (Control) | 9 | Participants | ||
| Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year | Immunosuppression With Paricalcitol | 12 | Participants | ||
| Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year | Immunosuppression Without Paricalcitol (Control) | 9 | Participants | ||
| Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year | Immunosuppression With Paricalcitol | 14 | Participants | ||
| Serum Parathyroid Hormone (PTH) Level Over Time | Immunosuppression Without Paricalcitol (Control) | Baseline PTH level | 236 | Full Range 50.12 to 1048.00 | pg/mL |
| Serum Parathyroid Hormone (PTH) Level Over Time | Immunosuppression With Paricalcitol | Baseline PTH level | 198 | Full Range 55.00 to 1266.00 | pg/mL |
| Serum Parathyroid Hormone (PTH) Level Over Time | Immunosuppression Without Paricalcitol (Control) | 21 day PTH level | 69 | Full Range 26.00 to 414.00 | pg/mL |
| Serum Parathyroid Hormone (PTH) Level Over Time | Immunosuppression With Paricalcitol | 21 day PTH level | 50 | Full Range 11.00 to 222.00 | pg/mL |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Immunosuppression Without Paricalcitol (Control) | 49 | |
| Overall Study | STARTED | Immunosuppression With Paricalcitol | 51 | |
| Overall Study | Continued in Study | Immunosuppression Without Paricalcitol (Control) | 45 | |
| Overall Study | Continued in Study | Immunosuppression With Paricalcitol | 46 | |
| Overall Study | COMPLETED | Immunosuppression Without Paricalcitol (Control) | 44 | |
| Overall Study | COMPLETED | Immunosuppression With Paricalcitol | 43 | |
| Overall Study | NOT COMPLETED | Immunosuppression Without Paricalcitol (Control) | 5 | |
| Overall Study | NOT COMPLETED | Immunosuppression With Paricalcitol | 8 |
Source ClinicalTrials.gov
Adverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Post transplant diabetes mellitus | Endocrine disorders | Immunosuppression Without Paricalcitol (Control) | 2 | 49 | 2 |
| other | Post transplant diabetes mellitus | Endocrine disorders | Immunosuppression With Paricalcitol | 4 | 51 | 4 |
| other | diarrhea | Gastrointestinal disorders | Immunosuppression Without Paricalcitol (Control) | 1 | 49 | 1 |
| other | diarrhea | Gastrointestinal disorders | Immunosuppression With Paricalcitol | 3 | 51 | 3 |
| other | allergy to Bactrim | Immune system disorders | Immunosuppression Without Paricalcitol (Control) | 0 | 49 | 0 |
| other | allergy to Bactrim | Immune system disorders | Immunosuppression With Paricalcitol | 1 | 51 | 1 |
| other | gout | Metabolism and nutrition disorders | Immunosuppression Without Paricalcitol (Control) | 0 | 49 | 0 |
| other | gout | Metabolism and nutrition disorders | Immunosuppression With Paricalcitol | 1 | 51 | 1 |
| other | symptomatic hypomagnesemia | Metabolism and nutrition disorders | Immunosuppression Without Paricalcitol (Control) | 0 | 49 | 0 |
| other | symptomatic hypomagnesemia | Metabolism and nutrition disorders | Immunosuppression With Paricalcitol | 1 | 51 | 1 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Immunosuppression Without Paricalcitol (Control) | ||
| Total, all-cause mortality | Immunosuppression With Paricalcitol | ||
| Total, other adverse events | Immunosuppression Without Paricalcitol (Control) | 14 | 49 |
| Total, other adverse events | Immunosuppression With Paricalcitol | 32 | 51 |
| Total, serious adverse events | Immunosuppression Without Paricalcitol (Control) | 16 | 49 |
| Total, serious adverse events | Immunosuppression With Paricalcitol | 27 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Immunosuppression Without Paricalcitol (Control) vs Immunosuppression With Paricalcitol: Number of Subjects Who Died or Lost Their Renal Graft During First Year | Trial comparisons |
| Immunosuppression Without Paricalcitol (Control) vs Immunosuppression With Paricalcitol: Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year | Trial comparisons |
| Immunosuppression Without Paricalcitol (Control) vs Immunosuppression With Paricalcitol: Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year | Trial comparisons |
| Immunosuppression Without Paricalcitol (Control) vs Immunosuppression With Paricalcitol: Number of Subjects With Hyperparathyroidism at One Year | Trial comparisons |
| Immunosuppression Without Paricalcitol (Control) vs Immunosuppression With Paricalcitol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00587158
GET https://conductscience.org/api/trials/v1/NCT00587158/results?page=2