HypophosphatemiaNCT01011114
Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant
A study testing Cinacalcet in people with Hypophosphatemia and Renal Transplant, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to determine whether cinacalcet, used in patients with secondary hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood phosphorus that is commonly seen in patients who have had a kidney transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypophosphatemia, Renal Transplant
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 15 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- renal transplant within last 3 months
- serum phosphorus less than 2.0 mg/dl
- serum creatinine less than 2.0 mg/dl
Who cannot join
- sensitivity to cinacalcet
- use of amitryptiline, desipramine, itraconazole, ketoconazole
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
The purpose of the study is to determine whether cinacalcet, used in patients with secondary hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood phosphorus that is commonly seen in patients who have had a kidney transplant.
Read the detailed description
Secondary hyperparathyroidism (SHPT), common in ESRD, persists following renal transplantation resulting in profound hypophosphatemia. This can lead to hemolysis, congestive heart failure, rhabdomyolysis. Phosphate repletion is difficult in view of the persistent SHPT: oral phosphate supplementation can lead to hypocalcemia, reduced 1,25-OH Vitamin D production, hypercalcemia and further hyperparathyroidism. In addition, phospho-soda has been associated with phosphate nephropathy and renal failure.
Cinacalcet HCl is a calcimimetic agent that has recently become a standard therapy in the treatment of SHPT in ESRD. It suppresses PTH secretion by acting as a modulator of the Calcium-sensing receptor on the PTH cell, causing the PTH cell to decrease production of parathyroid hormone. It is a very effective agent, producing significant reduction of PTH as well as improvement in calcium and phosphate metabolism in the dialysis patient. The drug is well-tolerated with minimal adverse effects. Cinacalcet has also been used to control hypercalcemia in renal transplant patients with persistent hyperparathyroidism. Short-term cinacalcet given for 2 to 4 weeks has normalized serum phosphorus and decreased urinary phosphate wasting in renal transplant recipients with stable graft function.
We hypothesize that Cinacalcet HCl will normalize the hypophosphatemia of early renal transplant by reducing the effects of PTH on the proximal renal tubular transport of phosphorus, thereby allowing phosphate reabsorption and decreasing urinary phosphate wasting.
- Conditions
- Hypophosphatemia, Renal Transplant
- Being tested
- Cinacalcet, Placebo
- Keywords
- hypophosphatemia, hyperparathyroidism, renal transplant
- Medical subject headings
- Hypophosphatemia, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Sensipar
cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.
PlaceboDrug
cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.
| Study group | Role | What they receive |
|---|---|---|
| Cincalcet | Active comparator | cinacalcet will be titrated as needed to achieve serum phosphorus of > 2.5 mg/dl randomized, placebo-controlled trial comparing the effect of cinacalcet to placebo in controlling serum phosphorus. All subjects will receive oral phosphorus supplementation and Vitamin D as needed to maintain baseline Phosphorus at ~ 2.5 mg/l. Receives: Drug: Cinacalcet |
| Control | Placebo comparator | subjects will receive placebo pill titrated as needed to achieve phosphorus > 2.5 mg/dl.
randomized, placebo-controlled trial comparing the effect of cinacalcet to placebo in controlling serum phosphorus. All subjects will receive oral phosphorus supplementation and Vitamin D as needed to maintain baseline Phosphorus at ~ 2.5 mEq/l. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in serum phosphorus
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2009
- Primary completion15 Oct 2015
- Study completion15 Oct 2015
Why it stopped: Study was not renewed with the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophosphatemiaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Coco, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011114
- Sponsor's protocol ID
- 09-07-203
- Status last verified
- Apr 2021
- First submitted
- 9 Nov 2009
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant
- ClinicalTrials.gov ID
- NCT01011114
- Acronym / sponsor ID
- 09-07-203
- Conditions
- Hypophosphatemia, Renal Transplant
- Keywords
- hypophosphatemia, hyperparathyroidism, renal transplant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was not renewed with the IRB
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- 15 Oct 2015 (actual)
- Study completion
- 15 Oct 2015 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether cinacalcet, used in patients with secondary hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood phosphorus that is commonly seen in patients who have had a kidney transplant.
Detailed description
Secondary hyperparathyroidism (SHPT), common in ESRD, persists following renal transplantation resulting in profound hypophosphatemia. This can lead to hemolysis, congestive heart failure, rhabdomyolysis. Phosphate repletion is difficult in view of the persistent SHPT: oral phosphate supplementation can lead to hypocalcemia, reduced 1,25-OH Vitamin D production, hypercalcemia and further hyperparathyroidism. In addition, phospho-soda has been associated with phosphate nephropathy and renal failure.
Cinacalcet HCl is a calcimimetic agent that has recently become a standard therapy in the treatment of SHPT in ESRD. It suppresses PTH secretion by acting as a modulator of the Calcium-sensing receptor on the PTH cell, causing the PTH cell to decrease production of parathyroid hormone. It is a very effective agent, producing significant reduction of PTH as well as improvement in calcium and phosphate metabolism in the dialysis patient. The drug is well-tolerated with minimal adverse effects. Cinacalcet has also been used to control hypercalcemia in renal transplant patients with persistent hyperparathyroidism. Short-term cinacalcet given for 2 to 4 weeks has normalized serum phosphorus and decreased urinary phosphate wasting in renal transplant recipients with stable graft function.
We hypothesize that Cinacalcet HCl will normalize the hypophosphatemia of early renal transplant by reducing the effects of PTH on the proximal renal tubular transport of phosphorus, thereby allowing phosphate reabsorption and decreasing urinary phosphate wasting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cincalcet | Active comparator | Drug: Cinacalcetcinacalcet will be titrated as needed to achieve serum phosphorus of > 2.5 mg/dl randomized, placebo-controlled trial comparing the effect of cinacalcet to placebo in controlling serum phosphorus. All subjects will receive oral phosphorus supplementation and Vitamin D as needed to maintain baseline Phosphorus at ~ 2.5 mg/l. |
| Control | Placebo comparator | Drug: Placebosubjects will receive placebo pill titrated as needed to achieve phosphorus > 2.5 mg/dl. randomized, placebo-controlled trial comparing the effect of cinacalcet to placebo in controlling serum phosphorus. All subjects will receive oral phosphorus supplementation and Vitamin D as needed to maintain baseline Phosphorus at ~ 2.5 mEq/l. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- renal transplant within last 3 months
- serum phosphorus less than 2.0 mg/dl
- serum creatinine less than 2.0 mg/dl
Key exclusion criteria (3 listed)
- sensitivity to cinacalcet
- use of amitryptiline, desipramine, itraconazole, ketoconazole
- pregnancy
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: Sensiparcinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated. | Drug | Cincalcet |
| Placebocinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated. | Drug | Control |
Primary outcome
improvement in serum phosphorus
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Study was not renewed with the IRB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
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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.
Maria Coco, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinacalcet in people with Hypophosphatemia and Renal Transplant, run by Montefiore Medical Center at 1 site in United States.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was stopped early (reason given: Study was not renewed with the IRB). Results are not available in the source record.
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?
improvement in serum phosphorus (time frame: 3 months). 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 23 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.