Trial · NCT01071070
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
NCT01071070, Phase 3, Completed, Abbott; results first posted 2012-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease. Trials, record NCT01071070. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01071070
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
- NCT number
- NCT01071070
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Chronic Kidney Disease
- Interventions
- paricalcitol
- First posted
- 2010-02-19
- Last updated
- 2012-01-26
- Results first posted
- 2012-01-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels | Baseline to 12 Weeks | The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values |
| Secondary | The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL | Baseline to 12 Weeks | The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL |
| Secondary | The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value | Baseline to 12 Weeks | |
| Secondary | The Change From Baseline to the Final Observation in Calcium | Baseline to 12 Weeks | |
| Secondary | The Change From Baseline to the Final Observation in Calcium-phosphorus Product | Baseline to 12 Weeks | |
| Secondary | The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure | Baseline to 12 Weeks | |
| Secondary | The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure | Baseline to 12 Weeks | |
| Secondary | The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate | Baseline to 12 Weeks | |
| Secondary | The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L) | Baseline to 12 weeks | The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels | Baseline to 12 Weeks | The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population. | participants | NUMBER |
| SECONDARY | The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL | Baseline to 12 Weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value | Baseline to 12 Weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | pg/mL | MEAN |
| SECONDARY | The Change From Baseline to the Final Observation in Calcium | Baseline to 12 Weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | mg/dL | MEAN |
| SECONDARY | The Change From Baseline to the Final Observation in Calcium-phosphorus Product | Baseline to 12 Weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | mg^2/dL^2 | MEAN |
| SECONDARY | The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure | Baseline to 12 Weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | mm Hg | MEAN |
| SECONDARY | The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure | Baseline to 12 Weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | mm Hg | MEAN |
| SECONDARY | The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate | Baseline to 12 Weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | beats per minute | MEAN |
| SECONDARY | The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L) | Baseline to 12 weeks | The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels | Group 1 | Yes | 93 | participants | |
| The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels | Group 2 | Yes | 57 | participants | |
| The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels | Group 1 | No | 12 | participants | |
| The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels | Group 2 | No | 45 | participants | |
| The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL | Group 1 | Yes | 19 | participants | |
| The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL | Group 2 | Yes | 21 | participants | |
| The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL | Group 1 | No | 89 | participants | |
| The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL | Group 2 | No | 87 | participants | |
| The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value | Group 1 | -342.57 | Standard Error 43.82 | pg/mL | |
| The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value | Group 2 | -191.53 | Standard Error 43.82 | pg/mL |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 108 | |
| Overall Study | STARTED | Group 2 | 108 | |
| Overall Study | COMPLETED | Group 1 | 104 | |
| Overall Study | COMPLETED | Group 2 | 105 | |
| Overall Study | NOT COMPLETED | Group 1 | 4 | |
| Overall Study | NOT COMPLETED | Group 2 | 3 |
Source ClinicalTrials.gov
Adverse events96
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 | Nephrogenic anaemia | Blood and lymphatic system disorders | Group 1 | 0 | 108 | |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | Group 2 | 1 | 108 | |
| other | Palpitations | Cardiac disorders | Group 1 | 1 | 108 | |
| other | Palpitations | Cardiac disorders | Group 2 | 1 | 108 | |
| other | Eyelid oedema | Eye disorders | Group 1 | 0 | 108 | |
| other | Eyelid oedema | Eye disorders | Group 2 | 1 | 108 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Group 1 | 0 | 108 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Group 2 | 1 | 108 | |
| other | Abdominal rigidity | Gastrointestinal disorders | Group 1 | 1 | 108 | |
| other | Abdominal rigidity | Gastrointestinal disorders | Group 2 | 0 | 108 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, all-cause mortality | Group 2 | ||
| Total, other adverse events | Group 1 | 29 | 108 |
| Total, other adverse events | Group 2 | 19 | 108 |
| Total, serious adverse events | Group 1 | 0 | 108 |
| Total, serious adverse events | Group 2 | 3 | 108 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1 vs Group 2: serious adverse events |
Source 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/NCT01071070
GET https://conductscience.org/api/trials/v1/NCT01071070/results?page=2