A Phase 1/2 interventional study of Cinacalcet HCl in Secondary Hyperparathyroidism and Hypercalcemia, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Montefiore Medical Center · Phase 1/2, Interventional, and Treatment
Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to treat secondary hyperparathyroidism in patients with kidney disease, may be effective in treating this condition in renal transplant recipients. The investigator team will study the effect of cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.
Secondary Hyperparathyroidism in the renal transplant recipient can cause abnormal bone and mineral metabolism, resulting in hypercalcemia that is detrimental to renal function, causing renal dysfunction and calcinosis. These patients often require parathyroidectomy to correct the hypercalcemia. Surgery is not without significant risk to the patient. Risks include vocal cord paralysis, protracted hypocalcemia, cardiac arrhythmias, muscle cramps. In addition, parathyroidectomy has been associated with subsequent renal impairment.
Cinacalcet is a calcimimetic agent that is very effective in the treatment of secondary hyperparathyroidism in patients with renal failure as well as in hypercalcemia of parathyroid cancer. There have been reports of short term Cinacalcet use in renal transplant recipients. Serum calcium was improved in these patients.
However, little is known about the effect of cinacalcet on bone activity and turnover. It is not known whether Cinacalcet causes low turnover bone activity with adynamic bone disease. It is known that low turnover bone disease in renal patients can by itself cause hypercalcemia as the bone becomes static and unable to respond to everyday calcium loads.
Studies have shown that adynamic bone can develop in renal transplant recipients under a variety of conditions. It is not known what effect, if any, cinacalcet has on the bone activity of renal transplant recipients with persistent secondary hyperparathyroidism.
The purpose of the study is to determine the effect of Cinacalcet on serum calcium, renal function and bone histology in renal transplant recipients.
This is a prospective, open-label study. Protocol procedures will include baseline and 6 month measurements of bone mineral density, bone biochemical parameters, glomerular filtration rate, anterior iliac crest bone biopsy. Subjects will start cinacalcet after the first biopsy. The medication will be titrated to normalize serum calcium. Medication will be supplied by the study. Serum electrolytes will be monitored as indicated.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's enrollment of 4 is below the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
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Exclusion Criteria:
Drug: Cinacalcet HCl
Normalization of Serum Calcium Levels
Serum calcium was to have been assessed by drawing venous blood samples for serum analysis. Normal blood calcium levels for adults range from approximately 8.5 to 10.4 mg/dL, but vary depending on laboratory reference ranges. Changes in serum calcium levels from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
Time frame: Baseline to 6 Months
Changes in Renal Function
Change in renal function from baseline was to have been assessed at 6 months based on a measurement of Glomerular Filtration Rate (GFR). Normal GFR ranges vary based on age, sex, and body size but are typically \> 90 mL/min/1.73 m\^2 for healthy individuals. Changes in renal glomerular filtration rate from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
Time frame: Baseline to 6 Months
Changes in Bone Mineral Density
Changes in bone mineral density was assessed using central dual energy x-ray absorptiometry (DXA or DEXA). DXA uses radiation to measure how much calcium and other minerals are in a specific area of the bone. For this study, changes in bone mineral density of the left hip, lumbar spine, and left forearm (vs baseline) have been summarized and reported as a percentage change from baseline. Statistical t-tests were not conducted due to limited sample size.
Time frame: Baseline to 6 Months
Changes in Bone Turnover Rate
Changes in bone turnover rate from baseline were to have been assessed by bone histology and histomorphometry. This was to have been conducted by an examination of bone biopsies, collected after double labeling with tetracycline compounds \~21 days prior to the procedure, to assess for bone turnover and structure. This was to have been a largely observational endpoint as no studies published at the time have described the effect of Cinacalcet HCl on bone histology.
Time frame: Baseline to 6 Months
| Milestone | Cinacalcet Hydrochloride (HCl) |
|---|---|
| Started | 4 |
| Completed | 3 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Serum calcium was to have been assessed by drawing venous blood samples for serum analysis. Normal blood calcium levels for adults range from approximately 8.5 to 10.4 mg/dL, but vary depending on laboratory reference ranges. Changes in serum calcium levels from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
No measurements were reported for this outcome.
Change in renal function from baseline was to have been assessed at 6 months based on a measurement of Glomerular Filtration Rate (GFR). Normal GFR ranges vary based on age, sex, and body size but are typically \> 90 mL/min/1.73 m\^2 for healthy individuals. Changes in renal glomerular filtration rate from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
No measurements were reported for this outcome.
Changes in bone mineral density was assessed using central dual energy x-ray absorptiometry (DXA or DEXA). DXA uses radiation to measure how much calcium and other minerals are in a specific area of the bone. For this study, changes in bone mineral density of the left hip, lumbar spine, and left forearm (vs baseline) have been summarized and reported as a percentage change from baseline. Statistical t-tests were not conducted due to limited sample size.
| percentage change from basline | Cinacalcet HCl |
|---|---|
| Left Hip | -6.9 (-9.5 to -2.7) |
| Spine - Lumbar | -12.9 (-17.3 to -2.4) |
| Left Forearm | -1.2 (-7.1 to -0.6) |
Changes in bone turnover rate from baseline were to have been assessed by bone histology and histomorphometry. This was to have been conducted by an examination of bone biopsies, collected after double labeling with tetracycline compounds \~21 days prior to the procedure, to assess for bone turnover and structure. This was to have been a largely observational endpoint as no studies published at the time have described the effect of Cinacalcet HCl on bone histology.
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cinacalcet HCl | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
Only 4 participants were enrolled into this study.
| Age, Categorical(Participants) | Cinacalcet HCl |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Cinacalcet HCl |
|---|---|
| Female | 3 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Cinacalcet HCl |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Cinacalcet HCl |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Cinacalcet HCl |
|---|---|
| United States | 4 |
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cinacalcet
Hyperparathyroidism, Secondary →