Chronic Allograft NephropathyPhase 3NCT00975000
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
A Phase 3 study testing Cinacalcet in people with Chronic Allograft Nephropathy and Chronic Kidney Disease, run by Amgen at 51 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure
- What is being tested?
- Cinacalcet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 51 sitesin 11 countries
- Study dates
- 3 Dec 2009to 16 Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
51 sites in 11 countries.
51 sites in 11 countries
United States15 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80045
Research Site
Bethlehem, Pennsylvania, 18017
Research Site
Chicago, Illinois, 60637
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Dallas, Texas, 75390
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Detroit, Michigan, 48202
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Evanston, Illinois, 60201
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Gainesville, Florida, 32610
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Houston, Texas, 77030
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Nashville, Tennessee, 37232
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New York, New York, 10032
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Phoenix, Arizona, 85012
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San Francisco, California, 94143
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Springfield, Massachusetts, 01107
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Tempe, Arizona, 85284
Canada5 sites
Research Site
Calgary, Alberta, T2N 2T9
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London, Ontario, N6A 5A5
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Ottawa, Ontario, K1H 7W9
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Toronto, Ontario, M5C 2T2
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Vancouver, British Columbia, V6Z 1Y6
France5 sites
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Bordeaux, 33076
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Montpellier, 34295
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Nantes, 44093
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Paris, 75743
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Toulouse, 31403
Poland5 sites
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Gdansk, 80-952
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Katowice, 40-027
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Lodz, 90-153
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Poznan, 60-539
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Szczecin, 70-111
Spain5 sites
Research Site
Barcelona, Cataluña, 08025
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Barcelona, Cataluña, 08036
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L'Hospitalet de Llobregat, Cataluña, 08907
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Málaga, AndalucÃ-a, 29010
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Madrid, 28041
Australia4 sites
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Camperdown, New South Wales, 2050
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Parkville, Victoria, 3050
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Westmead, New South Wales, 2145
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Woodville South, South Australia, 5011
Belgium3 sites
Research Site
Brussels, 1200
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Ghent, 9000
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Leuven, 3000
Italy3 sites
Research Site
Genova, 16132
Research Site
Milan, 20122
Research Site
Padova, 35128
Switzerland3 sites
Research Site
Bern, 3010
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Geneva, 1211
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Zurich, 8091
About this study
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
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.
- Conditions
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism, End Stage Renal Disease, Hyperparathyroidism
- Being tested
- Cinacalcet, Placebo
- Keywords
- Intervention, Cinacalcet, Sensipar, Mimpara, hyperparathyroidism, calcium, osteodystrophy, hypercalcemia, renal, transplant, acute rejection, kidney transplant failure, hypophosphatemia
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Hyperparathyroidism, Hypophosphatemia, Kidney Diseases, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Mimpara, Sensipar
Possible sequential doses are 30, 60, 90, 120, and 180 mg.
PlaceboDrug
Administered orally following the same dosing regimen as the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | 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. Receives: Drug: Cinacalcet |
| Placebo | Placebo comparator | Participants received placebo orally once daily for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Weeks 21 to 26 (EAP)
Secondary outcomes (8)
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck
Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
Measured: Baseline and Week 52
Change From Baseline to the EAP in Mean Serum Phosphorus
Measured: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Change From Baseline to Week 52 in eGFR
eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Measured: Baseline and Week 52
Change From Baseline to the EAP in Corrected Total Calcium
Measured: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)
Measured: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Change From Baseline to the EAP in Urine Phosphorus
Measured: Baseline and the EAP (mean of Weeks 22, 24, and 26)
Percentage of Participants With a Parathyroidectomy
Measured: 56 weeks
Time to Parathyroidectomy
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study start3 Dec 2009
- Primary completion13 Sep 2012
- Study completion16 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Allograft NephropathyStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975000
- Sponsor's protocol ID
- 20062007
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2009
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00975000
- Acronym / sponsor ID
- 20062007
- Conditions
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism, End Stage Renal Disease, Hyperparathyroidism
- Keywords
- Intervention, Cinacalcet, Sensipar, Mimpara, hyperparathyroidism, calcium, osteodystrophy, hypercalcemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2009 (actual)
- Primary completion
- 13 Sep 2012 (actual)
- Study completion
- 16 Apr 2013 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 29 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Experimental | Drug: CinacalcetParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo orally once daily for 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinacalcetAlso: Mimpara, SensiparPossible sequential doses are 30, 60, 90, 120, and 180 mg. | Drug | Cinacalcet |
| PlaceboAdministered orally following the same dosing regimen as the experimental arm. | Drug | Placebo |
Primary outcome
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)
8 secondary outcomes
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck
Time frame: Baseline and Week 52
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Chronic Allograft Nephropathy
RecruitingObservational study
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
51 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinacalcet in people with Chronic Allograft Nephropathy and Chronic Kidney Disease, run by Amgen at 51 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Canada, France, Poland, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.