Trial · NCT00110890
A Research Study for Patients With End-Stage Renal Disease (ESRD)
NCT00110890, Phase 4, Completed, Amgen; results first posted 2011-03-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Research Study for Patients With End-Stage Renal Disease (ESRD). Trials, record NCT00110890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00110890
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study for Patients With End-Stage Renal Disease (ESRD)
- NCT number
- NCT00110890
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 552 participants, actual
- Lead sponsor
- Amgen
- Conditions
- End Stage Renal Disease
- Interventions
- cinacalcet, Standard of care
- First posted
- 2005-05-17
- Last updated
- 2011-03-07
- Results first posted
- 2011-03-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Mean PTH ≤ 300 pg/mL | Efficacy Assessment Phase (weeks 17 to 23) | Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase |
| Secondary | Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL | Efficacy Assesment Phase (weeks 17-23) | Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase |
| Secondary | Number of Participants With Mean Ca x P < 55 mg^2/dL^2 | Efficacy Assessment Phase (weeks 17 to 23) | Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 during the efficacy assessment phase |
| Secondary | Number of Participants With Mean Serum Ca < 9.5 mg/dL | Efficacy Assessment Phase (weeks 17-23) | Number of participants with mean serum calcium (Ca) \< 9.5 mg/dL during the efficacy assessment phase |
| Secondary | Number of Participants With Mean Serum P < 5.5 mg/dL | Efficacy Assessment Phase (weeks 17 to 23) | Number of participants with mean serum phosphorus (P) \< 5.5 mg/dL during the efficacy assessment phase |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Mean PTH ≤ 300 pg/mL | Efficacy Assessment Phase (weeks 17 to 23) | Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF) | Participants | NUMBER |
| SECONDARY | Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL | Efficacy Assesment Phase (weeks 17-23) | Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF) | Participants | NUMBER |
| SECONDARY | Number of Participants With Mean Ca x P < 55 mg^2/dL^2 | Efficacy Assessment Phase (weeks 17 to 23) | Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF) | Participants | NUMBER |
| SECONDARY | Number of Participants With Mean Serum Ca < 9.5 mg/dL | Efficacy Assessment Phase (weeks 17-23) | Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF) | Participants | NUMBER |
| SECONDARY | Number of Participants With Mean Serum P < 5.5 mg/dL | Efficacy Assessment Phase (weeks 17 to 23) | Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Mean PTH ≤ 300 pg/mL | Cinacalcet | 262 | Participants | ||
| Number of Participants With Mean PTH ≤ 300 pg/mL | Standard of Care | 41 | Participants | ||
| Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL | Cinacalcet | 217 | Participants | ||
| Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL | Standard of Care | 29 | Participants | ||
| Number of Participants With Mean Ca x P < 55 mg^2/dL^2 | Cinacalcet | 282 | Participants | ||
| Number of Participants With Mean Ca x P < 55 mg^2/dL^2 | Standard of Care | 106 | Participants | ||
| Number of Participants With Mean Serum Ca < 9.5 mg/dL | Cinacalcet | 281 | Participants | ||
| Number of Participants With Mean Serum Ca < 9.5 mg/dL | Standard of Care | 61 | Participants | ||
| Number of Participants With Mean Serum P < 5.5 mg/dL | Cinacalcet | 231 | Participants | ||
| Number of Participants With Mean Serum P < 5.5 mg/dL | Standard of Care | 92 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cinacalcet | 368 | |
| Overall Study | STARTED | Standard of Care | 184 | |
| Overall Study | End of Dose Optimization Phase | Cinacalcet | 316 | |
| Overall Study | End of Dose Optimization Phase | Standard of Care | 170 | |
| Overall Study | End of Efficacy Assessment Phase | Cinacalcet | 280 | |
| Overall Study | End of Efficacy Assessment Phase | Standard of Care | 150 | |
| Overall Study | COMPLETED | Cinacalcet | 7 | |
| Overall Study | COMPLETED | Standard of Care | 5 | |
| Overall Study | NOT COMPLETED | Cinacalcet | 361 | |
| Overall Study | NOT COMPLETED | Standard of Care | 179 |
Source ClinicalTrials.gov
Adverse events274
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 | Diarrhoea | Gastrointestinal disorders | Standard Care | 12 | 182 | |
| other | Diarrhoea | Gastrointestinal disorders | Cinacalcet | 47 | 365 | |
| other | Nausea | Gastrointestinal disorders | Standard Care | 6 | 182 | |
| other | Nausea | Gastrointestinal disorders | Cinacalcet | 115 | 365 | |
| other | Vomiting | Gastrointestinal disorders | Standard Care | 12 | 182 | |
| other | Vomiting | Gastrointestinal disorders | Cinacalcet | 87 | 365 | |
| other | Nasopharyngitis | Infections and infestations | Standard Care | 6 | 182 | |
| other | Nasopharyngitis | Infections and infestations | Cinacalcet | 27 | 365 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Standard Care | 5 | 182 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Cinacalcet | 19 | 365 |
1 to 10 of 274Source ClinicalTrials.gov
See all 274 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Care | ||
| Total, all-cause mortality | Cinacalcet | ||
| Total, other adverse events | Standard Care | 31 | 182 |
| Total, other adverse events | Cinacalcet | 173 | 365 |
| Total, serious adverse events | Standard Care | 31 | 182 |
| Total, serious adverse events | Cinacalcet | 83 | 365 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cinacalcet vs Standard of Care: Number of Participants With Mean Serum Ca < 9.5 mg/dL | Trial comparisons |
| Cinacalcet vs Standard of Care: Number of Participants With Mean Serum P < 5.5 mg/dL | Trial comparisons |
| Cinacalcet vs Standard of Care: Number of Participants With Mean Ca x P < 55 mg^2/dL^2 | Trial comparisons |
| Cinacalcet vs Standard of Care: Number of Participants With Mean PTH ≤ 300 pg/mL | Trial comparisons |
| Cinacalcet vs Standard of Care: Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL | Trial comparisons |
| Cinacalcet vs Standard Care: 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/NCT00110890
GET https://conductscience.org/api/trials/v1/NCT00110890/events?page=2