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NCT00975000 · ClinicalTrials.gov registry record · Phase 3

Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
114
Enrollment target

NCT00975000 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 114 participants.

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The verdict

NCT00975000, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
114 participants
Enrollment target

Study Summary

Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.

Interventions

  • DRUG Placebo
  • DRUG Cinacalcet

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2009-12-03
Est. Completion 2013-04-16
Phase Phase 3

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT00975000

The ClinicalTrials.gov registry entry for NCT00975000 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00975000 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00975000 about?

NCT00975000 is a clinical study titled "Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients". Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures,...

What is the current status of trial NCT00975000?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2009-12-03. Estimated completion is 2013-04-16.

What interventions are being tested in trial NCT00975000?

The interventions under investigation include: Placebo (DRUG), Cinacalcet (DRUG).

Who is sponsoring clinical trial NCT00975000?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.