Trial · NCT01341782
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
NCT01341782, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2013-06-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism. Trials, record NCT01341782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01341782
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
- NCT number
- NCT01341782
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 255 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Secondary Hyperparathyroidism, Hemodialysis
- Interventions
- paricalcitol, maxacalcitol, paricalcitol placebo, maxacalcitol placebo
- First posted
- 2011-04-26
- Last updated
- 2013-06-06
- Results first posted
- 2013-06-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia | iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13). | The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. |
| Secondary | Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia | Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13). | The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. |
| Secondary | Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) | The last three weeks of treatment (Weeks 11, 12, and 13) | The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. |
| Secondary | Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) | The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. |
| Secondary | Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Weeks 2 to 13 | iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory. |
| Secondary | Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL | Weeks 2 to 13 | iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia | iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13). | The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia | Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13). | The Full Analysis Set (FAS) consists of all randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline iPTH measurement. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) | The last three weeks of treatment (Weeks 11, 12, and 13) | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Weeks 2 to 13 | Full analysis set | visits | MEAN |
| SECONDARY | Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL | Weeks 2 to 13 | Full analysis set | visits | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia | Paricalcitol | 27.7 | 95% Confidence Interval 19.92 to 36.68 | percentage of participants | |
| Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia | Maxacalcitol | 30.5 | 95% Confidence Interval 22.37 to 39.66 | percentage of participants | |
| Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia | Paricalcitol | 34.6 | 95% Confidence Interval 26.43 to 43.60 | percentage of participants | |
| Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia | Maxacalcitol | 39.1 | 95% Confidence Interval 30.56 to 48.08 | percentage of participants | |
| Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) | Paricalcitol | 31.5 | 95% Confidence Interval 23.55 to 40.33 | percentage of participants | |
| Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) | Maxacalcitol | 32.8 | 95% Confidence Interval 24.78 to 41.67 | percentage of participants | |
| Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Paricalcitol | 44.9 | 95% Confidence Interval 36.05 to 53.96 | percentage of participants | |
| Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Maxacalcitol | 50.8 | 95% Confidence Interval 41.80 to 59.72 | percentage of participants | |
| Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Paricalcitol | 3.9 | Standard Deviation 2.97 | visits | |
| Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline | Maxacalcitol | 5.3 | Standard Deviation 3.17 | visits |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paricalcitol | 127 | |
| Overall Study | STARTED | Maxacalcitol | 128 | |
| Overall Study | COMPLETED | Paricalcitol | 112 | |
| Overall Study | COMPLETED | Maxacalcitol | 114 | |
| Overall Study | NOT COMPLETED | Paricalcitol | 15 | |
| Overall Study | NOT COMPLETED | Maxacalcitol | 14 |
Source ClinicalTrials.gov
Adverse events76
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 | Constipation | Gastrointestinal disorders | Paricalcitol | 10 | 127 | |
| other | Constipation | Gastrointestinal disorders | Maxacalcitol | 7 | 128 | |
| other | Diarrhoea | Gastrointestinal disorders | Paricalcitol | 11 | 127 | |
| other | Diarrhoea | Gastrointestinal disorders | Maxacalcitol | 6 | 128 | |
| other | Vomiting | Gastrointestinal disorders | Paricalcitol | 11 | 127 | |
| other | Vomiting | Gastrointestinal disorders | Maxacalcitol | 7 | 128 | |
| other | Nasopharyngitis | Infections and infestations | Paricalcitol | 43 | 127 | |
| other | Nasopharyngitis | Infections and infestations | Maxacalcitol | 49 | 128 | |
| other | Contusion | Injury, poisoning and procedural complications | Paricalcitol | 8 | 127 | |
| other | Contusion | Injury, poisoning and procedural complications | Maxacalcitol | 7 | 128 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paricalcitol | ||
| Total, all-cause mortality | Maxacalcitol | ||
| Total, other adverse events | Paricalcitol | 118 | 127 |
| Total, other adverse events | Maxacalcitol | 123 | 128 |
| Total, serious adverse events | Paricalcitol | 10 | 127 |
| Total, serious adverse events | Maxacalcitol | 15 | 128 |
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 |
|---|
| Paricalcitol vs Maxacalcitol: 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/NCT01341782
GET https://conductscience.org/api/trials/v1/NCT01341782/events?page=2