An observational study in Secondary Hyperparathyroidism, sponsored by AbbVie (prior sponsor, Abbott). Completed at 13 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-03.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.
Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).
Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.
The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 86 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hemodialysis centers
Exclusion Criteria:
Planned for Zemplar administration due to secondary hyperparathyroidism
The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study
The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.
Time frame: 6 months
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study
The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.
Time frame: 6 months
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.
Time frame: 6 months
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study
The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.
Time frame: 6 months
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.
Time frame: 6 months
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study
The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at least once post-baseline during the study was recorded.
Time frame: 6 months
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at each visit post-baseline during the study was recorded.
Time frame: 6 months
Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination
The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks.
Time frame: 6 months
| Milestone | Stage 5 Chronic Kidney Disease |
|---|---|
| Started | 86 |
| Completed | 55 |
| Not completed | 31 |
| Withdrew: Study drug not available | 6 |
| Withdrew: Adverse event | 5 |
| Withdrew: Hyperphosphatemia | 5 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Kidney transplantation | 3 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Blood samples not available | 1 |
| Withdrew: Hyperphosphatemia and adverse event | 1 |
| Withdrew: Low intact parathyroid hormone | 1 |
| Withdrew: Serious adverse event | 1 |
The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study | 60.5 (49.3 to 70.8) |
The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| Baseline | 57.0 (45.8 to 67.6) |
| Post-baseline | 87.2 (78.3 to 93.4) |
The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| Baseline | 49.1 (35.4 to 62.9) |
| Visit 1 | 65.5 (51.4 to 77.8) |
| Visit 2 | 45.5 (32.0 to 59.4) |
| Visit 3 | 67.3 (53.3 to 79.3) |
| Visit 4 | 40.0 (27.0 to 54.1) |
| Visit 5 | 41.8 (28.7 to 55.9) |
| Visit 6 | 49.1 (35.4 to 62.9) |
The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study | 38.4 (28.1 to 49.5) |
The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| Visit 1 | 12.8 (6.6 to 21.7) |
| Visit 2 | 16.3 (9.2 to 25.8) |
| Visit 3 | 16.3 (9.2 to 25.8) |
| Visit 4 | 4.7 (1.3 to 11.5) |
| Visit 5 | 7.0 (2.6 to 14.6) |
| Visit 6 | 8.1 (3.3 to 16.1) |
The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at least once post-baseline during the study was recorded.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study | 10.5 (4.9 to 18.9) |
The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at each visit post-baseline during the study was recorded.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| Visit 1 | 1.2 (0.0 to 6.3) |
| Visit 2 | 2.3 (0.3 to 8.1) |
| Visit 3 | 2.3 (0.3 to 8.1) |
| Visit 4 | 4.7 (1.3 to 11.5) |
| Visit 5 | 2.3 (0.3 to 8.1) |
| Visit 6 | 0 (NA to NA) |
The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks.
| Percentage of participants | Stage 5 Chronic Kidney Disease |
|---|---|
| Hypercalcemia | 0 (NA to NA) |
| Hyperphosphatemia | 7.0 (2.6 to 14.6) |
Collected over Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 5 Chronic Kidney Disease | — | 3/86 (3.5%) | 6/86 (7%) |
| Event | Stage 5 Chronic Kidney Disease |
|---|---|
| Circulatory collapseVascular disorders | 1/86 |
| HypertensionVascular disorders | 1/86 |
| Post procedural hematomaInjury, poisoning and procedural complications | 1/86 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/86 |
| Event | Stage 5 Chronic Kidney Disease |
|---|---|
| Restless legs syndromeNervous system disorders | 2/86 |
| HeadacheNervous system disorders | 1/86 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/86 |
| Bone painMusculoskeletal and connective tissue disorders | 1/86 |
| NauseaGastrointestinal disorders | 1/86 |
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 1/86 |
| Pruritus generalizedSkin and subcutaneous tissue disorders | 1/86 |
| Age, Categorical(Participants) | Stage 5 Chronic Kidney Disease |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 86 |
| >=65 years | 0 |
| Age, Continuous(Participants) | Stage 5 Chronic Kidney Disease |
|---|---|
| Mean | 45.4 ± 12.6 |
| Sex: Female, Male(Participants) | Stage 5 Chronic Kidney Disease |
|---|---|
| Female | 48 |
| Male | 38 |
| Region of Enrollment(participants) | Stage 5 Chronic Kidney Disease |
|---|---|
| Russian Federation | 86 |
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AbbVie (prior sponsor, Abbott)