Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00975000 |
|
Recruitment Status :
Completed
First Posted : September 11, 2009
Results First Posted : January 29, 2016
Last Update Posted : October 17, 2018
|
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Drug: Cinacalcet Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 114 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism |
| Actual Study Start Date : | December 3, 2009 |
| Actual Primary Completion Date : | September 13, 2012 |
| Actual Study Completion Date : | April 16, 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Transplantation
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Cinacalcet
Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parthyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
|
Drug: Cinacalcet
Possible sequential doses are 30, 60, 90, 120, and 180 mg.
Other Names:
|
|
Placebo Comparator: Placebo
Participants received placebo orally once daily for 52 weeks.
|
Drug: Placebo
Administered orally following the same dosing regimen as the experimental arm. |
Primary Outcome Measures :
- 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) [ Time Frame: Weeks 21 to 26 (EAP) ]
Secondary Outcome Measures :
- Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck [ Time Frame: Baseline and Week 52 ]Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
- Change From Baseline to the EAP in Mean Serum Phosphorus [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Change From Baseline to Week 52 in eGFR [ Time Frame: Baseline and Week 52 ]eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
- Change From Baseline to the EAP in Corrected Total Calcium [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH) [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Change From Baseline to the EAP in Urine Phosphorus [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Percentage of Participants With a Parathyroidectomy [ Time Frame: 56 weeks ]
- Time to Parathyroidectomy [ Time Frame: 56 weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose
- May be the first kidney transplant or a repeat kidney transplant.
- Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening.
- Men or women ≥ 18 years at the start of Screening (ie, time of informed consent).
- Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period.
- iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).
Exclusion Criteria:
- Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet).
- Anticipated parathyroidectomy within 6 to12 months after Randomization.
- Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.
- Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening.
- Ongoing use of calcium supplements or use within 30 days prior to Screening.
- Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening.
- Ongoing use of a thiazide diuretic.
- Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication.
- Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975000
Locations
Show 51 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00975000 |
| Other Study ID Numbers: |
20062007 |
| First Posted: | September 11, 2009 Key Record Dates |
| Results First Posted: | January 29, 2016 |
| Last Update Posted: | October 17, 2018 |
| Last Verified: | September 2018 |
Keywords provided by Amgen:
|
Intervention Cinacalcet Sensipar Mimpara hyperparathyroidism calcium osteodystrophy |
hypercalcemia renal transplant acute rejection kidney transplant failure hypophosphatemia |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Hypophosphatemia Hyperparathyroidism Urologic Diseases Renal Insufficiency Parathyroid Diseases Endocrine System Diseases |
Phosphorus Metabolism Disorders Metabolic Diseases Cinacalcet Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |