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NCT00514813
Dynepo Long-Term Safety Study
Terminated
Phase 4
Results posted
Last updated 13 July 2021
What this trial tests
Phase 4 trial testing Dynepo in Anemia in 152 participants. Terminated before completion.
Timeline
6 June 2007
Primary endpoint
31 July 2008
31 July 2008
31 July 2008
Quick facts
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 152 |
| Start date | 6 June 2007 |
| Primary completion | 31 July 2008 |
| Estimated completion | 31 July 2008 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Dynepo — full drug profile →
Conditions studied
- Anemia — all drugs for Anemia →
- Kidney Failure, Chronic — all drugs for Kidney Failure, Chronic →
Sponsor
Shire — full company profile →
Who can join
18 and older, any sex, with Anemia or Kidney Failure, Chronic. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dynepo (Epoetin Delta) Twice Weekly (BIW)
Serious: 1/15 (7%)
Deaths: —
Dynepo Once Weekly (QW)
Serious: 14/84 (17%)
Deaths: —
Dynepo Once Every 2 Weeks (Q2W)
Serious: 6/47 (13%)
Deaths: —
Dynepo Once Every 4 Weeks (Q4W)
Serious: 1/4 (25%)
Deaths: —
Serious adverse events (22 terms)
| Reaction | System | Dynepo (Epoetin Delta) Twi… | Dynepo Once Weekly (QW) | Dynepo Once Every 2 Weeks … | Dynepo Once Every 4 Weeks … |
|---|---|---|---|---|---|
| Peritonitis | Gastrointestinal disorders | — | — | — | — |
| Traumatic fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Acute MI | Cardiac disorders | — | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Fecaloma | Gastrointestinal disorders | — | — | — | — |
| Hematemesis | Gastrointestinal disorders | — | — | — | — |
| Catheter-related complication | General disorders | — | — | — | — |
| Sudden death | General disorders | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Respiratory tract infection | Infections and infestations | — | — | — | — |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | — | — | — | — |
| Dialysis device complication | Injury, poisoning and procedural complications | — | — | — | — |
| Splenic rupture | Injury, poisoning and procedural complications | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Bursitis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
Other adverse events (29 terms — click to expand)
| Reaction | System | Dynepo (Epoetin Delta) Twi… | Dynepo Once Weekly (QW) | Dynepo Once Every 2 Weeks … | Dynepo Once Every 4 Weeks … |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | — | — | — | — |
| Hyperphosphatemia | Metabolism and nutrition disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Edema peripheral | General disorders | — | — | — | — |
| Vessel puncture site hematoma | General disorders | — | — | — | — |
| Catheter site infection | Infections and infestations | — | — | — | — |
| Oral herpes | Infections and infestations | — | — | — | — |
| Dialysis device complication | Injury, poisoning and procedural complications | — | — | — | — |
| Injury | Injury, poisoning and procedural complications | — | — | — | — |
| Hemaglobin decreased | Investigations | — | — | — | — |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | — | — | — | — |
| Skin ulcer | Skin and subcutaneous tissue disorders | — | — | — | — |
| Orthostatic hypertension | Vascular disorders | — | — | — | — |
Most-reported serious reactions: Peritonitis, Traumatic fracture, Acute MI, Angina pectoris, Cardiac failure, Coronary artery stenosis, Tachycardia, Abdominal pain upper.
Data from ClinicalTrials.gov NCT00514813 adverse events section.
Sponsor's own description
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00514813
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Dynepo
Trials testing the same drug.
- NCT00450333 — Dynepo Infrequent Dosing Study · Phase 3 · terminated
Other recruiting trials for Anemia
Currently open trials in the same condition.
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Other Shire trials
Trials by the same sponsor.
- NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
- NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
- NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
- NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
- NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT00514813 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shire
- Last refreshed: 13 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00514813.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing