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Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Phase 3 trial testing Cinacalcet in Chronic Allograft Nephropathy in 114 participants. Completed in 16 April 2013.
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 114 |
| Start date | 3 December 2009 |
| Primary completion | 13 September 2012 |
| Estimated completion | 16 April 2013 |
| Sites | 51 locations across France, Italy, Belgium, Austria, Germany, Poland, Canada, Switzerland |
Amgen — full company profile →
18 and older, any sex, with Chronic Allograft Nephropathy or Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 3.5 | |
| Cinacalcet | 78.9 |
Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.05 | -1.80 – 3.51 |
| Cinacalcet | 1.24 | -1.52 – 4.70 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.07 | ± 0.48 |
| Cinacalcet | 0.52 | ± 0.54 |
eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.06 | ± 8.70 |
| Cinacalcet | -0.37 | ± 11.69 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.14 | ± 0.51 |
| Cinacalcet | -1.53 | ± 0.74 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -10.6 | ± 106.4 |
| Cinacalcet | -127.9 | ± 254.2 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.47 | ± 31.51 |
| Cinacalcet | -2.62 | ± 43.93 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.0 | |
| Cinacalcet | 0.0 |
Time frame: 60 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Cinacalcet |
|---|---|---|---|
| Cytomegalovirus infection | Infections and infestations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Glaucoma | Eye disorders | — | — |
| Abdominal hernia | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Inguinal hernia | Gastrointestinal disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Pancreatitis acute | Gastrointestinal disorders | — | — |
| Influenza like illness | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — |
| Kidney transplant rejection | Immune system disorders | — | — |
| Transplant rejection | Immune system disorders | — | — |
| Cystitis | Infections and infestations | — | — |
| Escherichia sepsis | Infections and infestations | — | — |
| Escherichia urinary tract infection | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Gastroenteritis viral | Infections and infestations | — | — |
| Lung infection | Infections and infestations | — | — |
| Reaction | System | Placebo | Cinacalcet |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Malaise | General disorders | — | — |
| Hypercholesterolaemia | Metabolism and nutrition disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — |
| Influenza like illness | General disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Gout | Metabolism and nutrition disorders | — | — |
| Hyperlipidaemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| Osteoporosis | Musculoskeletal and connective tissue disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Cytomegalovirus infection, Anaemia, Neutropenia, Bradycardia, Glaucoma, Abdominal hernia, Abdominal pain upper, Colitis.
Data from ClinicalTrials.gov NCT00975000 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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