Trial · NCT00975000

Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

NCT00975000, Phase 3, Completed, Amgen; results first posted 2016-01-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients. Trials, record NCT00975000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00975000

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
NCT number: NCT00975000
Status: Completed
Phases: Phase 3
Enrollment: 114 participants, actual
Lead sponsor: Amgen
Conditions: Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism, End Stage Renal Disease, Hyperparathyroidism, Hypophosphatemia, Kidney Disease, Kidney Transplantation, Post Renal Transplantation
Interventions: Cinacalcet, Placebo
First posted: 2009-09-11
Last updated: 2018-10-17
Results first posted: 2016-01-29

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)	Weeks 21 to 26 (EAP)
Secondary	Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck	Baseline and Week 52	Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
Secondary	Change From Baseline to the EAP in Mean Serum Phosphorus	Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Change From Baseline to Week 52 in eGFR	Baseline and Week 52	eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Secondary	Change From Baseline to the EAP in Corrected Total Calcium	Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)	Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Change From Baseline to the EAP in Urine Phosphorus	Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Percentage of Participants With a Parathyroidectomy	56 weeks
Secondary	Time to Parathyroidectomy	56 weeks

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	Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)	Weeks 21 to 26 (EAP)	Full analysis set (all randomized participants excluding participants determined to have graft failure prior to week 26)	percentage of participants	NUMBER
SECONDARY	Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck	Baseline and Week 52	Full analysis set with available data	percent change	MEDIAN
SECONDARY	Change From Baseline to the EAP in Mean Serum Phosphorus	Baseline and the EAP (mean of Weeks 22, 24, and 26)	Full analysis set with available data	mg/dL	MEAN
SECONDARY	Change From Baseline to Week 52 in eGFR	Baseline and Week 52	Full analysis set with available data	mL/min/1.73 m²	MEAN
SECONDARY	Change From Baseline to the EAP in Corrected Total Calcium	Baseline and the EAP (mean of Weeks 22, 24, and 26)	Full analysis set	mg/dL	MEAN
SECONDARY	Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)	Baseline and the EAP (mean of Weeks 22, 24, and 26)	Full analysis set	pg/mL	MEAN
SECONDARY	Change From Baseline to the EAP in Urine Phosphorus	Baseline and the EAP (mean of Weeks 22, 24, and 26)	Full analysis set with available data	mg/dL	MEAN
SECONDARY	Percentage of Participants With a Parathyroidectomy	56 weeks	Full analysis set	percentage of participants	NUMBER
SECONDARY	Time to Parathyroidectomy	56 weeks	Full analysis set who underwent a parathyroidectomy

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)	Placebo	3.5		percentage of participants
Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)	Cinacalcet	78.9		percentage of participants
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck	Placebo	1.05	Inter-Quartile Range -1.80 to 3.51	percent change
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck	Cinacalcet	1.24	Inter-Quartile Range -1.52 to 4.70	percent change
Change From Baseline to the EAP in Mean Serum Phosphorus	Placebo	0.07	Standard Deviation 0.48	mg/dL
Change From Baseline to the EAP in Mean Serum Phosphorus	Cinacalcet	0.52	Standard Deviation 0.54	mg/dL
Change From Baseline to Week 52 in eGFR	Placebo	0.06	Standard Deviation 8.70	mL/min/1.73 m²
Change From Baseline to Week 52 in eGFR	Cinacalcet	-0.37	Standard Deviation 11.69	mL/min/1.73 m²
Change From Baseline to the EAP in Corrected Total Calcium	Placebo	-0.14	Standard Deviation 0.51	mg/dL
Change From Baseline to the EAP in Corrected Total Calcium	Cinacalcet	-1.53	Standard Deviation 0.74	mg/dL

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	57
Overall Study	STARTED	Cinacalcet	57
Overall Study	Completed Titration Phase	Placebo	54
Overall Study	Completed Titration Phase	Cinacalcet	55
Overall Study	Completed Efficacy Assessment Phase	Placebo	54
Overall Study	Completed Efficacy Assessment Phase	Cinacalcet	54
Overall Study	Completed Maintenance Phase	Placebo	52
Overall Study	Completed Maintenance Phase	Cinacalcet	52
Overall Study	COMPLETED	Placebo	52
Overall Study	COMPLETED	Cinacalcet	52

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events158

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
other	Anaemia	Blood and lymphatic system disorders	Placebo	3	57
other	Anaemia	Blood and lymphatic system disorders	Cinacalcet	1	57
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	2	57
other	Abdominal discomfort	Gastrointestinal disorders	Cinacalcet	3	57
other	Abdominal pain	Gastrointestinal disorders	Placebo	5	57
other	Abdominal pain	Gastrointestinal disorders	Cinacalcet	2	57
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	57
other	Diarrhoea	Gastrointestinal disorders	Cinacalcet	8	57
other	Nausea	Gastrointestinal disorders	Placebo	6	57
other	Nausea	Gastrointestinal disorders	Cinacalcet	7	57

1 to 10 of 158Source ClinicalTrials.gov

See all 158 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Cinacalcet
Total, other adverse events	Placebo	45	57
Total, other adverse events	Cinacalcet	45	57
Total, serious adverse events	Placebo	19	57
Total, serious adverse events	Cinacalcet	15	57

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
Cinacalcet vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00975000

GET https://conductscience.org/api/trials/v1/NCT00975000/events?page=2

API reference For AI assistants